Article: Rheumatology QC Suite

QC package for rheumatology: NSAIDs, glucocorticoids, methotrexate, biologics and supporting impurity/potency checks.

Package purpose

QC package for rheumatology: NSAIDs, glucocorticoids, methotrexate, biologics and supporting impurity/potency checks.

Utility count: 53. 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	Aceclofenac	`aceclofenac`	Aceclofenac Quality Checker — Aceclofenac quality assessment (BP/Ph.
2	Aceclofenac Paracetamol	`aceclofenac paracetamol`	Aceclofenac Paracetamol Quality Checker — Combined Analgesic (Ph.
3	Acemetacin	`acemetacin`	Acemetacin Quality Checker — Acemetacin quality assessment (BP/Ph.
4	Adalimumab	`adalimumab`	Adalimumab Quality Checker — Biologic Drug (Monoclonal Antibody) (Ph.
5	Atorvastatin Aspirin	`atorvastatin aspirin`	Atorvastatin Aspirin Quality Checker — Combo Product (Statin + NSAID) (Ph.
6	Betamethasone	`betamethasone`	Betamethasone Quality Checker — Betamethasone quality assessment (BP/Ph.
7	Carbocisteine	`carbocisteine`	Celecoxib Quality Checker — Celecoxib quality assessment (Ph.
8	Celecoxib	`celecoxib`	Celecoxib Quality Checker — Celecoxib quality assessment (Ph.
9	Dexamethasone	`dexamethasone`	Dexamethasone Quality Checker — Dexamethasone quality assessment (BP/Ph.
10	Diclofenac Sodium	`diclofenac sodium`	Diclofenac Sodium Quality Checker — Diclofenac sodium quality assessment (Ph.
11	ELISA Specific Protein	`elisa specific protein checker`	ELISA Specific Protein Checker — Protein content verification (ICH Q6B) ℹ️ The utility verifies ELISA results: API, HCP, aggregates in biologics.
12	Etanercept	`etanercept`	Etanercept Quality Checker — Biologic Drug (TNF-Receptor Fusion Protein) (Ph.
13	Etodolac	`etodolac`	Etodolac Quality Checker — Etodolac quality assessment (Ph.
14	Etoricoxib	`etoricoxib`	Etoricoxib Quality Checker — COX-2 Inhibitor (Ph. Eur., USP) ℹ️ The utility checks assay, chlorinated/oxidized impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
15	Flurbiprofen	`flurbiprofen`	Flurbiprofen Quality Checker — Flurbiprofen quality assessment (Ph.
16	Folinic Acid	`folinic acid`	Folinic Acid Quality Checker — Vitamin B9 Analog (Ph.
17	Golimumab	`golimumab`	Golimumab Quality Checker — Biologic Drug (Anti-TNF-a mAb) (Ph.
18	Hydroxychloroquine Sulfate	`hydroxychloroquine sulfate`	Hydroxychloroquine Sulfate Quality Checker — Hydroxychloroquine sulfate quality assessment (Ph.
19	Ibuprofen	`ibuprofen`	Ibuprofen Quality Checker — Ibuprofen quality assessment (BP/Ph.
20	Ibuprofen Paracetamol	`ibuprofen paracetamol`	Ibuprofen Paracetamol Quality Checker — Combo Analgesic (USP/Ph.
21	Indomethacin	`indomethacin`	Indomethacin Quality Checker — Indomethacin quality assessment (Ph.
22	Infliximab	`infliximab`	Infliximab Quality Checker — Infliximab quality assessment (BP/Ph.
23	Ixekizumab	`ixekizumab`	Ixekizumab Quality Checker — Biologic Drug (Anti-IL-17A mAb) (Ph.
24	Ketoprofen	`ketoprofen`	Ketoprofen Quality Checker — Ketoprofen quality assessment (Ph.
25	Ketorolac	`ketorolac`	Ketorolac Quality Checker — NSAID (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized impurities, toluene/acetonitrile, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
26	Leucovorin	`leucovorin`	Leucovorin Quality Checker — Vitamin B9 Analog (Ph.
27	MAT Pyrogen	`mat pyrogen checker`	MAT Pyrogen Checker — Pyrogenicity assessment via Monocyte Activation Test (Ph.
28	Meloxicam	`meloxicam`	Meloxicam Quality Checker — Meloxicam quality assessment (Ph.
29	Melting Point Verifier	`melting point verifier`	Melting Point Verifier — Проверка температуры плавления (Ph.
30	Methotrexate	`methotrexate`	Methotrexate Quality Checker — Methotrexate quality assessment (Ph.
31	Methylprednisolone	`methylprednisolone`	Methylprednisolone Quality Checker — Methylprednisolone quality assessment (Ph.
32	Nabumetone	`nabumetone`	Nabumetone Quality Checker — Nabumetone quality assessment (Ph.
33	Naproxen	`naproxen`	Naproxen Quality Checker — Naproxen quality assessment (Ph.
34	Nimesulide	`nimesulide`	Nimesulide Quality Checker — Nimesulide quality assessment (Ph.
35	Penicillamine	`penicillamine`	Penicillamine Quality Checker — Penicillamine quality assessment (Ph.
36	Piroxicam	`piroxicam`	Piroxicam Quality Checker — Piroxicam quality assessment (Ph.
37	Prednisolone	`prednisolone`	Prednisolone Quality Checker — Glucocorticosteroid (Ph.
38	Prednisone	`prednisone`	Prednisone Quality Checker — Glucocorticoid (Ph. Eur., USP) ℹ️ The utility checks assay, specific rotation, DCM, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ CRITICAL!
39	Residual Host Protein	`residual host protein checker`	Residual Host Protein Checker — Host Cell Protein (HCP) verification ℹ️ The utility verifies HCP levels in biologics (mAbs, recombinant proteins).
40	Rituximab	`rituximab`	Rituximab Quality Checker — Biologic Drug (Anti-CD20 mAb) (Ph.
41	Secukinumab	`secukinumab`	Secukinumab Quality Checker — Biologic Drug (Anti-IL-17A mAb) (Ph.
42	Sulfasalazine	`sulfasalazine`	Sulfasalazine Quality Checker — Sulfasalazine quality assessment (Ph.
43	Tocilizumab	`tocilizumab`	Tocilizumab Quality Checker — Biologic Drug (Anti-IL-6R mAb) (Ph.
44	Ustekinumab	`ustekinumab`	Ustekinumab Quality Checker — Biologic Drug (Anti-IL-12/23 mAb) (Ph.
45	Erbium-169	`erbium169`	Utility description: Erbium-169 Erbium-169 Quality Checker — Radiocolloid for Synovectomy (Ph.
46	Phosphorus-32 Chromic Phosphate	`phosphorus32 chromic phosphate checker`	Phosphorus-32 Chromic Phosphate Quality Checker — P-32 Colloid for Radiosynovectomy ℹ️ Utility checks critical parameters of colloidal Phosphorus-32: • Radionuclidic purity (≥99.
47	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.
48	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.
49	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.
50	Dissolution Apparatus 1 & 2	`dissolution apparatus12`	Dissolution Apparatus 1 & 2 Quality Checker — Dissolution Testing (Apparatus 1 & 2) ℹ️ Utility assesses dissolution profile of solid dosage forms according to USP using Apparatus 1 (Basket) and Apparatus 2 (Paddle): • Mean Dissolution ≥ Q (…
51	Raman Identity	`raman identity`	Raman Identity Quality Checker — Substance Identification by Raman Spectroscopy ℹ️ Utility checks critical parameters of Raman spectral identification: • Hit Quality Index (HQI / Correlation): ≥0.
52	Semisolid IVRT	`semisolid ivrtquality checker`	Semisolid IVRT Quality Checker — In Vitro Release Testing for Semisolid Dosage Forms ℹ️ Utility assesses the release kinetics of drug substances from ointments, creams, and gels according to USP : • Release Rate (must match reference produc…
53	SPR Binding Affinity	`sprbinding affinity`	SPR Binding Affinity Quality Checker — Control of Binding Affinity (SPR) ℹ️ Utility assesses the kinetics of interaction of biological products (e.