Article: Gynecology QC Suite

QC package for gynecology: hormones, contraceptives, uterotonics, anti-infectives and women’s-health medicines.

Package purpose

QC package for gynecology: hormones, contraceptives, uterotonics, anti-infectives and women’s-health medicines.

Utility count: 41. 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	Anastrozole	`anastrozole`	Anastrozole Quality Checker — Anastrozole quality assessment (BP/Ph.
2	Benzalkonium Chloride	`benzalkonium chloride`	Benzalkonium Chloride Quality Checker — Benzalkonium Chloride (Antiseptic, Preservative) (Ph.
3	Chlormadinone Acetate	`chlormadinone acetate`	Chlormadinone Acetate Quality Checker — Chlormadinone Acetate (Progestogen) (Ph.
4	Clotrimazole	`clotrimazole`	Clotrimazole Quality Checker — Clotrimazole quality assessment (Ph.
5	Copper IUD	`copper iudquality checker`	Copper IUD Quality Checker — Copper Intrauterine Device (ISO 7439, ISO 10993) ℹ️ The utility checks copper content, corrosion, dimensions, mechanical properties, biocompatibility (cytotoxicity, endotoxins), sterility, packaging integrity.
6	Cyproterone Acetate Ethinylestradiol	`cyproterone acetate ethinylestradiol`	Cyproterone Acetate + Ethinylestradiol Quality Checker — Combined Tablets (Diane-35, Androcur) (Ph.
7	Desogestrel	`desogestrel`	Desogestrel Quality Checker — Desogestrel (Progestogen for Mini-Pills and Implants) (Ph.
8	Dienogest	`dienogest`	Dienogest Quality Checker — Dienogest (Progestogen for Endometriosis and COCs) (Ph.
9	Drospirenone	`drospirenone`	Drospirenone Quality Checker — Drospirenone (Anti-Aldosterone Progestogen for COCs) (Ph.
10	Estradiol	`estradiol`	Estradiol Quality Checker — Estradiol quality assessment (BP/Ph.
11	Ethinylestradiol Chlormadinone	`ethinylestradiol chlormadinone`	Ethinylestradiol + Chlormadinone Acetate Quality Checker — Combined Tablets (Belara) (Ph.
12	Ethinylestradiol Desogestrel	`ethinylestradiol desogestrel`	Ethinylestradiol + Desogestrel Quality Checker — Combined Tablets (Novinet, Mercilon) (Ph.
13	Ethinylestradiol Dienogest	`ethinylestradiol dienogest`	Ethinylestradiol + Dienogest Quality Checker — Combined Tablets (Claira, Nata) (Ph.
14	Ethinylestradiol Drospirenone	`ethinylestradiol drospirenone`	Ethinylestradiol + Drospirenone Quality Checker — Combined Tablets (Yasmin, Jeanine, Drospirenone) (Ph.
15	Ethinylestradiol Gestodene	`ethinylestradiol gestodene`	Ethinylestradiol + Gestodene Quality Checker — Combined Tablets (Minisiston, Marvelon) (Ph.
16	Ethinylestradiol Levonorgestrel	`ethinylestradiol levonorgestrel`	Ethinylestradiol + Levonorgestrel Quality Checker — Combined Tablets (Regulon, Microgynon, Norinyl) (Ph.
17	Ethinylestradiol Nomegestrol	`ethinylestradiol nomegestrol`	Ethinylestradiol + Nomegestrol Acetate Quality Checker — Combined Tablets (Zoely) (Ph.
18	Ethinylestradiol Norethisterone	`ethinylestradiol norethisterone`	Ethinylestradiol + Norethisterone Quality Checker — Combined Tablets (Microgynon 30, Norinyl-1, Ovcon) (Ph.
19	Ethinylestradiol Norgestimate	`ethinylestradiol norgestimate`	Ethinylestradiol + Norgestimate Quality Checker — Combined Tablets (Cilest, Sprintec) (Ph.
20	Etonogestrel Ethinylestradiol Ring	`etonogestrel ethinylestradiol ring`	Etonogestrel + Ethinylestradiol Ring Quality Checker — Vaginal Ring (NuvaRing, Vaginorm) (Ph.
21	Etonogestrel Implant	`etonogestrel implant`	Etonogestrel Implant Quality Checker — Subdermal Etonogestrel Implant (Implanon, Nexplanon, Jadelle) (Ph.
22	Fluconazole	`fluconazole`	Fluconazole Quality Checker — Fluconazole quality assessment (BP/Ph.
23	Folic Acid	`folic acid`	Folic Acid Quality Checker — Vitamin B9 (Ph. Eur. 2.8.1) ℹ️ The utility checks assay, specific rotation, UV ratio, impurities, loss on drying. ℹ️ Does not use machine learning — rule-based logic only. ⚠️ Critical for vitamin products, dieta…
24	Levonorgestrel	`levonorgestrel`	Levonorgestrel Quality Checker — Levonorgestrel (Substance) (Ph.
25	Levonorgestrel Emergency	`levonorgestrel emergency`	Levonorgestrel Emergency Quality Checker — Emergency Contraceptive Tablets (Postinor, Escapelle) (Ph.
26	Levonorgestrel IUS	`levonorgestrel iusquality checker`	Levonorgestrel IUS Quality Checker — Levonorgestrel Intrauterine System (Mirena, Kyleena, Skyla) (Ph.
27	Metronidazole	`metronidazole`	Metronidazole Quality Checker — Metronidazole quality assessment (Ph.
28	Mifepristone	`mifepristone`	Mifepristone Quality Checker — Mifepristone (Antiprogestogen, RU-486) (USP, EP draft) ℹ️ The utility checks assay, specific rotation, melting point (with decomposition), UV ratio, critical impurities (11β-hydroxy, 17α-epimer), loss on dryin…
29	Nomegestrol Acetate	`nomegestrol acetate`	Nomegestrol Acetate Quality Checker — Nomegestrol Acetate (Highly Selective Progestogen) (Ph.
30	Nonoxynol9	`nonoxynol9`	Nonoxynol-9 Quality Checker — Nonoxynol-9 (Spermicidal Surfactant) (Ph.
31	Norelgestromin Ethinylestradiol Patch	`norelgestromin ethinylestradiol patch`	Norelgestromin + Ethinylestradiol Patch Quality Checker — Transdermal Patch (Evra) (Ph.
32	Norethisterone	`norethisterone`	Norethisterone Quality Checker — Norethisterone (First-Generation Progestogen) (Ph.
33	Norgestimate	`norgestimate`	Norgestimate Quality Checker — Norgestimate quality assessment (Ph.
34	Progesterone	`progesterone`	Progesterone Quality Checker — Hormone (Ph. Eur., USP) ℹ️ The utility checks assay, isomer/oxidized/hydrolysis impurities, toluene/acetonitrile/dichloromethane, dissolution profile. ℹ️ Does not use machine learning — rule-based logic only.…
35	Testosterone Undecanoate	`testosterone undecanoate`	Testosterone Undecanoate Quality Checker — Testosterone Undecanoate (Testosterone Ester for Replacement Therapy) (Ph.
36	Ulipristal Acetate	`ulipristal acetate`	Ulipristal Acetate Quality Checker — Ulipristal Acetate (Selective Progesterone Receptor Modulator) (Ph.
37	Fluorine-18 FES	`fluorine18 fes`	Fluorine-18 FES Quality Checker — Fluorine-18 FES for PET Imaging of Estrogen Receptors ℹ️ Utility checks critical parameters of [18F]Fluoroestradiol (FES): • Radionuclidic purity (≥99.
38	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.
39	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.
40	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.
41	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.