Article: Lumex QC Suite

A single Lumex package combining the former Lumex and Lumex2 sets: instrumental and general pharmaceutical QC, AAS/ICP, CE, HPLC, NIR/PAT, stability, dissolution, content uniformity, system suitability and statistical control.

Package purpose

Utility count: 107. The package is intended for QC laboratories, QA, CSV and LIMS/ELN/MES integration.

Data

Typical flow: instrument or LIMS creates input.csv, the utility performs rule-based checks and returns output.json.

Validation

Each utility is supported by URS/FS and scenarios that can be used for IQ/OQ/PQ preparation.

Licensing

Licensing can be discussed as an as-is legal-entity licence without resale rights, a LIMS/ELN/MES integration module, or a pilot package for a production site/laboratory. Representative contacts are rendered from the portal configuration.

Utilities and checked parameters

#	API / product	Utility	Key checks
1	AAS Aluminum Limit Test	`aas aluminum limit test`	Utility description: AAS Aluminum Limit Test AAS Aluminum Limit Test — Aluminum Limit Determination (AAS) ℹ️ Utility checks aluminum content using Atomic Absorption Spectrometry: • Limit: ≤2.
2	AAS Dialysis Solution Metals	`aas dialysis solution metals`	Utility description: AAS Dialysis Solution Metals AAS Dialysis Solution Metals — Metal Control in Dialysis Solutions ℹ️ Utility checks electrolytes and toxic metals content: • Electrolytes: Ca, Mg, Na, K (composition control) • Toxic metals…
3	AAS Elemental Impurities Class 1	`aas elemental impurities class1`	Utility description: AAS Elemental Impurities Class 1 AAS Elemental Impurities Class 1 — Class 1 Elements Control (ICH Q3D) ℹ️ Utility checks Class 1 elemental impurities according to ICH Q3D: • Cadmium (Cd) ≤0.
4	AAS Elemental Impurities Class 2A	`aas elemental impurities class2 a`	Utility description: AAS Elemental Impurities Class 2A AAS Elemental Impurities Class 2A — Class 2A Elements Control (ICH Q3D) ℹ️ Utility checks Class 2A elemental impurities according to ICH Q3D: • Cobalt (Co) ≤5.
5	AAS/ICP-MS Elemental Impurities Class 2B	`aas elemental impurities class2 b`	Utility description: AAS/ICP-MS Elemental Impurities Class 2B AAS/ICP-MS Elemental Impurities Class 2B — Class 2B Elements Control (ICH Q3D) ℹ️ Utility checks 14 Class 2B elements according to ICH Q3D: • Thallium (Tl) ≤0.
6	AAS Heavy Metals Plant Material	`aas heavy metals plant material`	Utility description: AAS Heavy Metals Plant Material AAS Heavy Metals Plant Material — Heavy Metals in Plant Material ℹ️ Utility checks toxic elements content in medicinal plants: • Lead (Pb) ≤5.
7	AAS Nickel Hydrogenated Oils	`aas nickel hydrogenated oils`	Utility description: AAS Nickel Hydrogenated Oils AAS Nickel Hydrogenated Oils — Nickel Control in Hydrogenated Oils ℹ️ Utility checks residual nickel content after catalytic hydrogenation: • Nickel (Ni) ≤1.
8	Acyclovir Impurity Checker	`acyclovir impurity checker`	Utility description: Acyclovir Impurity Checker Acyclovir Impurity Checker — Acyclovir Impurity Control ℹ️ Utility checks critical quality parameters of acyclovir: • Assay (98.
9	Amlodipine Besylate Chiral Checker	`amlodipine besylate chiral checker`	Utility description: Amlodipine Besylate Chiral Checker Amlodipine Besylate Chiral Checker — Amlodipine Enantiomeric Purity Control ℹ️ Utility checks critical chiral purity parameters: • Assay (98.
10	Amoxicillin Degradation Checker	`amoxicillin degradation checker`	Utility description: Amoxicillin Degradation Checker Amoxicillin Degradation Checker — Amoxicillin Degradation Product Control ℹ️ Utility checks critical stability parameters of amoxicillin: • Assay (95.
11	Capillary ID Aprotinin	`capillary id aprotinin`	Utility description: Capillary ID Aprotinin Capillary ID Aprotinin — Aprotinin Identification (CE) ℹ️ Utility checks capillary electrophoresis parameters for aprotinin: • Migration time (comparison with standard) • Purity by peak area (≥98.
12	Capillary ID Galantamine	`capillary id galantamine`	Utility description: Capillary ID Galantamine Capillary ID Galantamine — Galantamine Identification (CE) ℹ️ Utility checks capillary electrophoresis parameters for galantamine: • Migration time (comparison with standard) • Purity by peak ar…
13	Capillary ID Glutathione	`capillary id glutathione`	Utility description: Capillary ID Glutathione Capillary ID Glutathione — Glutathione Identification (CE) ℹ️ Utility checks capillary electrophoresis parameters for glutathione: • Migration time (comparison with standard) • Purity by peak ar…
14	Capillary ID Sodium Lauryl Sulfoacetate	`capillary id sodium lauryl sulfoacetate`	Utility description: Capillary ID Sodium Lauryl Sulfoacetate Capillary ID Sodium Lauryl Sulfoacetate — SLSA Identification (CE) ℹ️ Utility checks capillary electrophoresis parameters for SLSA: • Migration time (comparison with standard) • P…
15	CE DNA Vaccine Purity Checker	`ce dna vaccine purity checker`	Utility description: CE DNA Vaccine Purity Checker CE DNA Vaccine Purity Checker — Plasmid DNA Vaccine Purity Control (CE) ℹ️ Utility checks plasmid DNA isoform distribution: • Supercoiled form (CCC) ≥80.
16	CE Erythropoietin Isoform Checker	`ce erythropoietin isoform checker`	Utility description: CE Erythropoietin Isoform Checker CE Erythropoietin Isoform Checker — Erythropoietin Isoform Control (CE) ℹ️ Utility checks erythropoietin sialylation profile: • Acidic isoforms (high sialylation) ≥40.
17	CE mAb Charge Variant Checker	`ce m ab charge variant checker`	Utility description: CE mAb Charge Variant Checker CE mAb Charge Variant Checker — Monoclonal Antibody Charge Variant Analysis (CE/CIEF) ℹ️ Utility checks charge heterogeneity of monoclonal antibodies: • Acidic variants (≤25.
18	CE Peptide Map Validator	`ce peptide map validator`	Utility description: CE Peptide Map Validator CE Peptide Map Validator — Peptide Mapping Validation (CE/HPLC) ℹ️ Utility compares sample peptide map with reference: • Sequence coverage ≥95.
19	CE Recombinant Protein Purity	`ce recombinant protein purity`	Utility description: CE Recombinant Protein Purity CE Recombinant Protein Purity — Recombinant Protein Purity Control (SDS-CE) ℹ️ Utility checks electrophoretic purity of protein under denaturing conditions: • Main Band ≥95.
20	Ceftriaxone Sodium Purity Checker	`ceftriaxone sodium purity checker`	Utility description: Ceftriaxone Sodium Purity Checker Ceftriaxone Sodium Purity Checker — Ceftriaxone Sodium Purity Control ℹ️ Utility checks critical quality parameters of ceftriaxone sodium: • Assay (96.
21	Chondroitin Sulfate Assay Checker	`chondroitin sulfate assay checker`	Utility description: Chondroitin Sulfate Assay Checker Chondroitin Sulfate Assay Checker — Chondroitin Sulfate Quality Control ℹ️ Utility checks critical parameters of chondroitin sulfate: • Assay (dry basis) ≥90.
22	Ciprofloxacin Impurity Checker	`ciprofloxacin impurity checker`	Utility description: Ciprofloxacin Impurity Checker Ciprofloxacin Impurity Checker — Ciprofloxacin Impurity Control ℹ️ Utility checks critical quality parameters of ciprofloxacin: • Assay (98.
23	Collagen Hydrolysate Peptide Profile Checker	`collagen hydrolysate peptide profile checker`	Utility description: Collagen Hydrolysate Peptide Profile Checker Collagen Hydrolysate Peptide Profile Checker — Collagen Peptide Profile Analysis ℹ️ Utility checks molecular weight distribution of collagen peptides: • Low MW fraction ( 5 k…
24	Daclatasvir Assay Checker	`daclatasvir assay checker`	Utility description: Daclatasvir Assay Checker Daclatasvir Assay Checker — Daclatasvir Quality Control ℹ️ Utility checks critical parameters of daclatasvir: • Assay (on dry basis) 98.
25	Drotaverine Hydrochloride Quality Checker	`drotaverine hydrochloride checker`	Utility description: Drotaverine Hydrochloride Quality Checker Drotaverine Hydrochloride Quality Checker — Drotaverine Hydrochloride (No-Spa) ℹ️ Utility checks critical parameters of Drotaverine Hydrochloride API: • Assay (99.
26	Fluconazole Related Substances Checker	`fluconazole related substances checker`	Utility description: Fluconazole Related Substances Checker Fluconazole Related Substances Checker — Fluconazole (Related Substances Control) ℹ️ Utility checks the impurity profile of Fluconazole API: • Assay (99.
27	Fluorat Aflatoxin Screener	`fluorat aflatoxin screener`	Utility description: Fluorat Aflatoxin Screener Fluorat Aflatoxin Screener — Aflatoxin Screener (B1, B2, G1, G2) ℹ️ Utility checks mycotoxin content in herbal raw materials: • Aflatoxin B1 ≤ 2.
28	Fluorat Aluminum Vaccines	`fluorat aluminum vaccines`	Utility description: Fluorat Aluminum Vaccines Fluorat Aluminum Vaccines — Aluminum Control in Adjuvanted Vaccines ℹ️ Utility checks aluminum adjuvant parameters in vaccines: • Total aluminum content (200–1250 mcg/dose) • pH (5.
29	Fluorat Porphyrin Checker	`fluorat porphyrin checker`	Utility description: Fluorat Porphyrin Checker Fluorat Porphyrin Checker — Porphyrin and Precursor Control ℹ️ Utility checks levels of porphyrins and their precursors in biological fluids: • Uroporphyrin • Coproporphyrin • Protoporphyrin •…
30	Fluorat Quinine Sulfate Checker	`fluorat quinine sulfate checker`	Utility description: Fluorat Quinine Sulfate Checker Fluorat Quinine Sulfate Checker — Quinine Sulfate ℹ️ Utility checks critical parameters of Quinine Sulfate API: • Assay (99.
31	Fluorat Riboflavin Quantifier	`fluorat riboflavin quantifier`	Utility description: Fluorat Riboflavin Quantifier Fluorat Riboflavin Quantifier — Riboflavin (Vitamin B2) ℹ️ Utility checks critical parameters of Riboflavin API: • Assay (97.
32	Glucosamine Sulfate Purity Checker	`glucosamine sulfate purity checker`	Utility description: Glucosamine Sulfate Purity Checker Glucosamine Sulfate Purity Checker — Glucosamine Sulfate (Purity Control) ℹ️ Utility checks critical parameters of Glucosamine Sulfate API: • Assay (98.
33	Heparin Sodium Molecular Weight Checker	`heparin sodium molecular weight checker`	Utility description: Heparin Sodium Molecular Weight Checker Heparin Sodium Molecular Weight Checker — Heparin Sodium (Molecular Weight Control) ℹ️ Utility checks critical parameters of Heparin Sodium: • Weight-average molecular weight (Mw)…
34	Iron Sucrose Complex Checker	`hyaluronic acid molecular weight checker`	Utility description: Iron Sucrose Complex Checker Iron Sucrose Complex Checker — Iron(III) Hydroxide Sucrose Complex ℹ️ Utility checks critical parameters per Ph.
35	Ibuprofen Related Substances Checker	`ibuprofen related substances checker`	Utility description: Ibuprofen Related Substances Checker Ibuprofen Related Substances Checker — Ibuprofen (Related Substances Control) ℹ️ Utility checks impurity profile per Ph.
36	InfraLUM ID Acyclovir	`infra lum id acyclovir`	Utility description: InfraLUM ID Acyclovir InfraLUM ID Acyclovir — Acyclovir Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
37	InfraLUM ID Amlodipine	`infra lum id amlodipine`	Utility description: InfraLUM ID Amlodipine InfraLUM ID Amlodipine — Amlodipine Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
38	InfraLUM ID Amoxicillin	`infra lum id amoxicillin`	Utility description: InfraLUM ID Amoxicillin InfraLUM ID Amoxicillin — Amoxicillin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
39	InfraLUM ID Ceftriaxone	`infra lum id ceftriaxone`	Utility description: InfraLUM ID Ceftriaxone InfraLUM ID Ceftriaxone — Ceftriaxone Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
40	InfraLUM ID Ciprofloxacin	`infra lum id ciprofloxacin`	Utility description: InfraLUM ID Ciprofloxacin InfraLUM ID Ciprofloxacin — Ciprofloxacin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
41	InfraLUM ID Daclatasvir	`infra lum id daclatasvir`	Utility description: InfraLUM ID Daclatasvir InfraLUM ID Daclatasvir — Daclatasvir Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
42	InfraLUM ID Drotaverine	`infra lum id drotaverine`	Utility description: InfraLUM ID Drotaverine InfraLUM ID Drotaverine — Drotaverine Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
43	InfraLUM ID Fluconazole	`infra lum id fluconazole`	Utility description: InfraLUM ID Fluconazole InfraLUM ID Fluconazole — Fluconazole Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
44	InfraLUM ID Ibuprofen	`infra lum id ibuprofen`	Utility description: InfraLUM ID Ibuprofen InfraLUM ID Ibuprofen — Ibuprofen Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
45	InfraLUM ID Levofloxacin	`infra lum id levofloxacin`	Utility description: InfraLUM ID Levofloxacin InfraLUM ID Levofloxacin — Levofloxacin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
46	InfraLUM ID Losartan	`infra lum id losartan`	Utility description: InfraLUM ID Losartan InfraLUM ID Losartan — Losartan Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
47	InfraLUM ID Metformin	`infra lum id metformin`	Utility description: InfraLUM ID Metformin InfraLUM ID Metformin — Metformin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
48	InfraLUM ID Omeprazole	`infra lum id omeprazole`	Utility description: InfraLUM ID Omeprazole InfraLUM ID Omeprazole — Omeprazole Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
49	InfraLUM ID Paracetamol	`infra lum id paracetamol`	Utility description: InfraLUM ID Paracetamol InfraLUM ID Paracetamol — Paracetamol Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
50	InfraLUM ID Ranitidine	`infra lum id ranitidine`	Utility description: InfraLUM ID Ranitidine InfraLUM ID Ranitidine — Ranitidine Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
51	InfraLUM ID Ribavirin	`infra lum id ribavirin`	Utility description: InfraLUM ID Ribavirin InfraLUM ID Ribavirin — Ribavirin Identification by IR Spectroscopy ℹ️ Utility checks IR spectrum compliance with reference (Ph.
52	InfraLUM ID Sofosbuvir	`infra lum id sofosbuvir`	Utility description: InfraLUM ID Sofosbuvir InfraLUM ID Sofosbuvir — Sofosbuvir Identification via IR Spectroscopy ℹ️ Utility checks critical identification parameters of sofosbuvir via IR spectrum: • Correlation coefficient with reference…
53	Insulin Human HPLC Checker	`insulin human hplcchecker`	Utility description: Insulin Human HPLC Checker Insulin Human HPLC Checker — Human Insulin Quality Control via HPLC ℹ️ Utility checks critical parameters of human insulin via HPLC: • Assay content: 95.
54	Levofloxacin Optical Isomer Checker	`levofloxacin optical isomer checker`	Utility description: Levofloxacin Optical Isomer Checker Levofloxacin Optical Isomer Checker — Control of Levofloxacin Optical Isomerism ℹ️ Utility checks critical chiral purity parameters of levofloxacin: • Content of active S-(-)-isomer (…
55	Losartan Potassium Impurity Checker	`losartan potassium impurity checker`	Utility description: Losartan Potassium Impurity Checker Losartan Potassium Impurity Checker — Control of Losartan Potassium Impurities ℹ️ Utility checks critical purity parameters of losartan potassium: • Assay content: 98.
56	Mercury Analyzer Fish Oil	`mercury analyzer fish oil`	Utility description: Mercury Analyzer Fish Oil Mercury Analyzer Fish Oil — Analysis of Mercury and Heavy Metals in Fish Oil ℹ️ Utility checks critical safety parameters of fish oil: • Total Mercury: ≤100 ppb (0.
57	Mercury Analyzer Vaccine Thimerosal	`mercury analyzer vaccine thimerosal`	Utility description: Mercury Analyzer Vaccine Thimerosal Mercury Analyzer Vaccine Thimerosal — Control of Thimerosal in Vaccines ℹ️ Utility checks critical parameters of thimerosal preservative in vaccines: • Thimerosal concentration: 40–60…
58	Mercury Analyzer Water Hemodialysis	`mercury analyzer water hemodialysis`	Utility description: Mercury Analyzer Water Hemodialysis Mercury Analyzer Water Hemodialysis — Quality Control of Hemodialysis Water ℹ️ Utility checks critical chemical purity parameters of hemodialysis water: • Total Mercury: ≤0.
59	Metformin Hydrochloride Purity Checker	`metformin hydrochloride purity checker`	Utility description: Metformin Hydrochloride Purity Checker Metformin Hydrochloride Purity Checker — Control of Metformin Hydrochloride Impurities ℹ️ Utility checks critical purity parameters of metformin hydrochloride: • Assay content: 98.
60	Methylparaben Propylparaben Checker	`methylparaben propylparaben checker`	Utility description: Methylparaben Propylparaben Checker Methylparaben Propylparaben Checker — Quality Control of Paraben Mixtures ℹ️ Utility checks critical parameters of methylparaben and propylparaben mixture: • Methylparaben: 0.
61	NIR API Content Checker	`nir api content checker`	Utility description: NIR API Content Checker NIR API Content Checker — Quantitative Analysis of API via Near-Infrared Spectroscopy ℹ️ Utility checks critical parameters of quantitative NIR analysis: • Predicted API Content (Assay): 95.
62	NIR Blend Uniformity Checker	`nir blend uniformity checker`	Utility description: NIR Blend Uniformity Checker NIR Blend Uniformity Checker — Assessment of Blend Homogeneity via Near-Infrared Spectroscopy ℹ️ Utility checks critical parameters of powder blend homogeneity: • Mean API Content: 95.
63	NIR Moisture Content Checker	`nir moisture content checker`	Utility description: NIR Moisture Content Checker NIR Moisture Content Checker — Moisture Control via Near-Infrared Spectroscopy ℹ️ Utility checks critical parameters of moisture determination via NIR: • Predicted Moisture Content: ≤2.
64	Omeprazole Assay Checker	`omeprazole assay checker`	Utility description: Omeprazole Assay Checker Omeprazole Assay Checker — Omeprazole Quality Control ℹ️ Utility checks critical quality parameters of omeprazole: • Assay content: 98.
65	Paracetamol Impurity Checker	`paracetamol impurity checker`	Utility description: Paracetamol Impurity Checker Paracetamol Impurity Checker — Control of Paracetamol Impurities ℹ️ Utility checks critical purity parameters of paracetamol: • Assay content: 99.
66	Polyethylene Glycol Impurity Checker	`polyethylene glycol impurity checker`	Utility description: Polyethylene Glycol Impurity Checker Polyethylene Glycol Impurity Checker — Control of Polyethylene Glycol (PEG) Impurities ℹ️ Utility checks critical safety parameters of PEG: • Ethylene Glycol: ≤10 ppm • Diethylene Gl…
67	Polymer ID EVA	`polymer id eva`	Utility description: Polymer ID EVA Polymer ID EVA — Identification and Composition Control of Ethylene Vinyl Acetate (EVA) ℹ️ Utility checks critical identification parameters of EVA copolymer: • Correlation coefficient with reference IR s…
68	Polymer ID Polyethylene	`polymer id polyethylene`	Utility description: Polymer ID Polyethylene Polymer ID Polyethylene — Identification of Polyethylene (PE) via IR Spectroscopy ℹ️ Utility checks critical identification parameters of polyethylene: • Correlation coefficient with reference IR…
69	Polymer ID Polypropylene	`polymer id polypropylene`	Utility description: Polymer ID Polypropylene Polymer ID Polypropylene — Identification of Polypropylene (PP) via IR Spectroscopy ℹ️ Utility checks critical identification parameters of polypropylene: • Correlation coefficient with referenc…
70	Polysorbate 80 Peroxide Checker	`polysorbate80 peroxide checker`	Utility description: Polysorbate 80 Peroxide Checker Polysorbate 80 Peroxide Checker — Control of Peroxides in Polysorbate 80 ℹ️ Utility checks critical oxidation parameters of Polysorbate 80: • Peroxide Value: ≤5.
71	Ranitidine Impurity Checker	`ranitidine impurity checker`	Utility description: Ranitidine Impurity Checker Ranitidine Impurity Checker — Control of Ranitidine Impurities (NDMA Focus) ℹ️ Utility checks critical quality and safety parameters of ranitidine: • Assay content: 98.
72	Ribavirin Purity Checker	`ribavirin purity checker`	Utility description: Ribavirin Purity Checker Ribavirin Purity Checker — Ribavirin Quality Control ℹ️ Utility checks critical quality parameters of ribavirin: • Assay content: 98.
73	Sodium Benzoate Preservative Checker	`sodium benzoate preservative checker`	Utility description: Sodium Benzoate Preservative Checker Sodium Benzoate Preservative Checker — Sodium Benzoate Quality Control ℹ️ Utility checks critical quality parameters of sodium benzoate: • Assay content: 99.
74	Sofosbuvir Impurity Profiler	`sofosbuvir impurity profiler`	Utility description: Sofosbuvir Impurity Profiler Sofosbuvir Impurity Profiler — Sofosbuvir Impurity Profiling ℹ️ Utility checks critical purity parameters of sofosbuvir: • Assay content: 98.
75	Vitamin A Quantifier	`vitamin aquantifier`	Utility description: Vitamin A Quantifier Vitamin A Quantifier — Quantitative Analysis of Vitamin A (Retinol) ℹ️ Utility checks critical quality parameters of Vitamin A: • Content: 90.
76	Vitamin D3 Quantifier	`vitamin d3 quantifier`	Utility description: Vitamin D3 Quantifier Vitamin D3 Quantifier — Quantitative Analysis of Vitamin D3 (Cholecalciferol) ℹ️ Utility checks critical quality parameters of Vitamin D3: • Content: 90.
77	Vitamin E Quantifier	`vitamin equantifier`	Utility description: Vitamin E Quantifier Vitamin E Quantifier — Quantitative Analysis of Vitamin E (Alpha-Tocopherol) ℹ️ Utility checks critical quality parameters of Vitamin E: • Alpha-Tocopherol Content: ≥960 mg/g (≥96.
78	AAS Catalyst Residues Pd Pt Rh	`aas catalyst residues pd pt rh`	Utility description: AAS Catalyst Residues Pd Pt Rh AAS Catalyst Residues Pd Pt Rh — Control of Residual Catalysts (Pd, Pt, Rh) ℹ️ Utility checks critical parameters of platinum group metals content: • Palladium (Pd): ≤10.
79	AAS Dialysis Fluid Monitor	`aas dialysis fluid monitor`	Utility description: AAS Dialysis Fluid Monitor AAS Dialysis Fluid Monitor — Quality Control of Hemodialysis Solutions ℹ️ Utility checks critical parameters of dialyzing fluids: • Calcium (Ca): within ±5% of label claim • Magnesium (Mg): wi…
80	AAS Glass Leachables Test	`aas glass leachables test`	Utility description: AAS Glass Leachables Test AAS Glass Leachables Test — Evaluation of Leachables from Glass Containers ℹ️ Utility checks critical quality parameters of glass containers (USP / Ph.
81	AAS Microelements Supplements	`aas microelements supplements`	Utility description: AAS Microelements Supplements AAS Microelements Supplements — Control of Microelements in Vitamin Complexes ℹ️ Utility checks content of key microelements in supplements and drugs: • Zinc (Zn): 90–110% of Label Claim •…
82	CE Chiral Separation Checker	`ce chiral separation checker`	Utility description: CE Chiral Separation Checker CE Chiral Separation Checker — Control of Enantiomeric Purity (CE) ℹ️ Utility checks critical parameters of chiral separation by Capillary Electrophoresis: • Enantiomeric Excess (EE): ≥99.
83	CE Glycosylation Profiler	`ce glycosylation profiler`	Utility description: CE Glycosylation Profiler CE Glycosylation Profiler — Analysis of Protein Glycosylation Profile (CE) ℹ️ Utility checks critical parameters of recombinant protein glycosylation: • Asialo forms: ≤5.
84	CE Inorganic Ions Analyzer	`ce inorganic ions analyzer`	Utility description: CE Inorganic Ions Analyzer CE Inorganic Ions Analyzer — Analysis of Inorganic Ions by Capillary Electrophoresis ℹ️ Utility checks content of key inorganic anions and cations: • Chlorides (Cl-): ≤50.
85	CE mAb Aggregates & Fragments	`ce m ab aggregates fragments`	Utility description: CE mAb Aggregates & Fragments CE mAb Aggregates & Fragments — Control of mAb Aggregates and Fragments (CE-SDS) ℹ️ Utility checks critical purity parameters of monoclonal antibodies: • Aggregates (High Molecular Weight,…
86	CE Peptide Map Fingerprint	`ce peptide map fingerprint`	Utility description: CE Peptide Map Fingerprint CE Peptide Map Fingerprint — Peptide Mapping of Proteins (CE) ℹ️ Utility checks critical parameters of recombinant protein peptide maps: • Peak Count: ≥20 (depends on protein and protease) • S…
87	Content Uniformity Acceptance Value	`content uniformity acceptance value`	Utility description: Content Uniformity Acceptance Value Content Uniformity Acceptance Value — Calculation of AV for Uniformity of Dosage Units ℹ️ Utility calculates Acceptance Value (AV) according to USP and Ph.
88	Dissolution Profile f2 Calculator	`dissolution profile f2 calculator`	Utility description: Dissolution Profile f2 Calculator Dissolution Profile f2 Calculator — Calculation of Dissolution Profile Similarity Factor ℹ️ Utility checks similarity of dissolution profiles of two batches (e.
89	Excipient Incoming QC Library	`excipient incoming qc library`	Utility description: Excipient Incoming QC Library Excipient Incoming QC Library — Identification of Excipients (IR Spectroscopy) ℹ️ Utility checks identity of incoming excipients using IR spectroscopy: • Hit Quality Index (HQI / Correlatio…
90	Excipients Sugars Polyols HPLC	`excipients sugars polyols hplc`	Utility description: Excipients Sugars Polyols HPLC Excipients Sugars Polyols HPLC — Quality Control of Sugars and Polyols (HPLC) ℹ️ Utility checks critical parameters of excipients (sugars/polyols): • Assay: usually 98.
91	Fluorat B-Complex Vitamins	`fluorat b complex vitamins`	Utility description: Fluorat B-Complex Vitamins Fluorat B-Complex Vitamins — Analysis of B-Group Vitamins by Fluorometry ℹ️ Utility checks critical parameters of water-soluble vitamin content: • Vitamin B2 (Riboflavin): 90–110% of Label Cla…
92	Fluorat Enzyme Fluorogenic Assays	`fluorat enzyme fluorogenic assays`	Utility description: Fluorat Enzyme Fluorogenic Assays Fluorat Enzyme Fluorogenic Assays — Analysis of Enzymatic Activity by Fluorometric Method ℹ️ Utility checks critical parameters of enzymatic reactions with fluorogenic substrates: • Enz…
93	Fluorat Mycotoxins Ochratoxin	`fluorat mycotoxins ochratoxin`	Utility description: Fluorat Mycotoxins Ochratoxin Fluorat Mycotoxins Ochratoxin — Ochratoxin A Screening by Fluorometry ℹ️ Utility checks critical parameters of Ochratoxin A content: • Concentration: ≤5.
94	Fluorat Nucleic Acids Quantifier	`fluorat nucleic acids quantifier`	Utility description: Fluorat Nucleic Acids Quantifier Fluorat Nucleic Acids Quantifier — Quantitative Analysis of DNA/RNA by Fluorometry ℹ️ Utility checks critical parameters of nucleic acid quantification: • Concentration: above limit of d…
95	Fluorat Reactive Oxygen Species	`fluorat reactive oxygen species`	Utility description: Fluorat Reactive Oxygen Species Fluorat Reactive Oxygen Species — Analysis of Reactive Oxygen Species (ROS) ℹ️ Utility checks critical parameters of oxidative stress: • Net Fluorescence: > 0 RFU • Signal-to-Noise Ratio…
96	Genotoxic Impurity Screener M7	`genotoxic impurity screener m7`	Utility description: Genotoxic Impurity Screener M7 Genotoxic Impurity Screener M7 — Control of Genotoxic Impurities (ICH M7) ℹ️ Utility checks critical parameters of mutagenic impurity content: • Nitrosamines: ≤ Specific Limit (e.
97	LabWare CDS Bridge Connector	`lab ware cds bridge connector`	Utility description: LabWare CDS Bridge Connector LabWare CDS Bridge Connector — Integration of Analytical Data with LabWare LIMS ℹ️ Utility converts analysis results into JSON format compatible with LabWare LIMS: • Standard structure: Head…
98	Mercury Speciation: Methyl vs Inorganic	`mercury speciation methyl vs inorganic`	Utility description: Mercury Speciation: Methyl vs Inorganic Mercury Speciation: Methyl vs Inorganic — Analysis of Mercury Forms ℹ️ Utility checks critical parameters of mercury speciation: • Total Mercury: ≤100 ppb (example) • Methylmercur…
99	Method Validation Data Packager	`method validation data packager`	Utility description: Method Validation Data Packager Method Validation Data Packager — Assessment of Analytical Method Validation Parameters ℹ️ Utility checks key validation parameters according to ICH Q2(R1) and USP : • Linearity: R² ≥ 0.
100	Moisture Sorption Isotherm Processor	`moisture sorption isotherm processor`	Utility description: Moisture Sorption Isotherm Processor Moisture Sorption Isotherm Processor — Analysis of Moisture Sorption Isotherms (DVS) ℹ️ Utility checks critical parameters of substance-water interaction: • Equilibrium moisture at 7…
101	NIR Real-Time Blend Endpoint	`nir real time blend endpoint`	Utility description: NIR Real-Time Blend Endpoint NIR Real-Time Blend Endpoint — Determination of Blending Endpoint in Real-Time (PAT) ℹ️ Utility controls blending process using NIR spectroscopy data: • Homogeneity Metric (e.
102	Outlier Detection Grubb Dixon	`outlier detection grubb dixon`	Utility description: Outlier Detection Grubb Dixon Outlier Detection Grubb Dixon — Statistical Outlier Analysis (Grubbs and Dixon) ℹ️ Utility applies Grubbs' and Dixon's criteria to detect anomalous values: • Grubbs' Test (G): For normally…
103	Polymorph Screening NIR/FTIR	`polymorph screening nir ftir`	Utility description: Polymorph Screening NIR/FTIR Polymorph Screening NIR/FTIR — Identification of Polymorphic Forms (IR/NIR) ℹ️ Utility checks critical parameters of polymorph identification: • Correlation with reference spectrum of form:…
104	Preservatives Combo QC	`preservatives combo qc`	Utility description: Preservatives Combo QC Preservatives Combo QC — Control of Combined Preservatives ℹ️ Utility checks critical parameters of preservative mixtures: • Sodium Benzoate: 90–110% of Label Claim • Potassium Sorbate: 90–110% of…
105	Stability Shelf Life Predictor	`stability shelf life predictor`	Utility description: Stability Shelf Life Predictor Stability Shelf Life Predictor — Shelf Life Prediction (Arrhenius Model) ℹ️ Utility estimates potential drug shelf life based on degradation kinetics: • Input: Accelerated testing results…
106	System Suitability Parameters Checker	`system suitability parameters checker`	Utility description: System Suitability Parameters Checker System Suitability Parameters Checker — Chromatography System Suitability Test ℹ️ Utility checks critical System Suitability Test (SST) parameters per USP / Ph.
107	Tablet Coating Uniformity NIR	`tablet coating uniformity nir`	Utility description: Tablet Coating Uniformity NIR Tablet Coating Uniformity NIR — Assessment of Tablet Coating Uniformity (NIR) ℹ️ Utility checks critical parameters of film coating quality: • Mean coating thickness: within ±10% of target…