API / PRODUCT
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Progesterone
Chemical Name | ：Progesterone |
Category | ： |
Specification | ：EP |
HS Code | ：29372290.00 |
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Structure Formula | ： |
CAS Number | ：76-25-5 |
Molecular Formula | ：C24H31FO6 |
Usage | ：It is suitable for all kinds of skin diseases (e.g., neurodermatitis, eczema, psoriasis, etc.), joint pain, bronchial asthma, shoulder inflammation around, tenosynovitis, acute sprain, slow lumbocrural pain and eye inflammation, etc. |
Items | Standard |
|---|---|
Character | White to creamy white crystalline powder |
Identification | A: Complies by IR B: Complies by UV |
Specific rotation | +118°~+130° |
Related substances | Individual impurity ≤0.3% Total impurity ≤0.8% |
Loss on drying | ≤1.5% |
Heavy metals | ≤25ppm |
Methanol | ≤3000ppm |
Ethanol | ≤5000ppm |
Acetone | ≤5000ppm |
Chloroform | ≤60ppm |
* DMF | ≤880ppm |
Assay | It should contain 97.0% to 102.0% of C24H31PO6 calculated on the dried basis |
1， Argentinian National Institute of Drugs
Instituto Nacional de Medicamentos (INAME)
2， Australian?Therapeutic?Goods?Administration (TGA)
3， Belgian Federal Agency for Medicines and Health Products
Agence Fédérale des Médicaments et des Produits de Santé(AFMPS)
Federaal Agentschap voor Geneesmiddelen enGezondheidsproducten (FAGG)
4， Canadian?Health?Products and?Food?Branch?Inspectorate(HPFBI)
5， Taiwan?Food and?Drug?Administration?(TFDA)
7， Czech State Institute for Drug Control
Státní ústav pro Kontrolu Lé?iv (SúKL)
8， Czech?Institute for?State?Control of?Veterinary?Biologicals?and?Medicines (ISCVBM)
9， Danish?Health and?Medicines?Authority (DHMA)
10， Finnish?Medicines?Agency (FIMEA)
11， French National Agency for Medicines and Health Products Safety
Agence nationale de sécurité du médicament et des produits de santé (ANSM)
12， 13， German Federal Ministry of Health * 14， Icelandic?Medicines?Agency?(IMA) 20， Indonesian?National?Agency for?Drug and?Food?Control (NADFC) 21， Health?Products?Regulatory?Authority?(HPRA) 22， Italian Medicines Agency 23， Japanese?Pharmaceuticals and?Medical?Devices?Agency(PMDA) 24， Korea (Republic of)?Ministry of?Food and?Drug?Safety?(MFDS) 25， Malaysian?National?Pharmaceutical?Control?Bureau?(NPCB) 26， Dutch Health Care Inspectorate* 27， (Medsafe) 28， Norwegian?Medicines?Agency?(NOMA) 29， Polish?Main?Pharmaceutical?Inspectorate (MPI) 30， Romanian?National?Agency for?Medicines and?MedicalDevices (NAMMD) 31， South African?Medicines?Control?Council?(MCC) 32， Spanish Agency of Medicines and Medical Devices?* Agencia Espa?ola de Medicamentos y Productos Sanitarios(AEMPS) 33， Swedish?Medical?Products?Agency?(MPA) 34， (MHRA) 36， U.S.?Food and?Drug?Administration (US FDA) 37， European Directorate for the Quality of Medicines & HealthCare （EDQM） 38， European Medicines Agency（EMA） 39， World Health Organization（WHO）
Bundesministerium für Gesundheit (BMG)
Agenzia Italiana del Farmaco (AIFA)
Inspectie voor de Gezondheidszorg (IGZ)