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Gestodene Usp Ip Ep Bp Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Gestodene CAS No: 60282- 87- 3

Batch No: GES/ 011114 A. R. No 14/ FP/ GES/ 0111

Date of Manufacture Nov- 2014 Date of Analysis 02- 11- 14

Batch Quantity 100 kg Date of Retest Jan- 2017

Sr. No Test Results Acceptance Criteria

1. Appearance Complies White or yellowish crystalline powder

2. Identification Complies

- 190º IR

Specification optical rotation: - 188° to

- 198°

( 0.01g/ ml, methanol)

3. Solubility Complies Slightly soluble in water, freely soluble

in dilute acetic acid and methanol,

slightly soluble in alcohol

4. Melting point 198.5- 200℃ 196 ℃ to 200℃

5. Solubility Practically insolubIe in water, freely

solubIe in rnethyIene chIoride, solubIe

in methanoI, sparingIy soluble in96 % ethanol.

6. Loss on drying 0.04% NMT 0.5%

7. Residue on ignition 0.04% NMT 0.3%

8. Related substances

Impurity A

Impurity B

Impurity C

Impurity I

Impurity L

Individual impurity

Total impurities

0.05%

ND

0.09%

0.15%

NMT 0.3%

NMT 0.2%

NMT 0.15%

NMT 0.1%

NMT 0.5%

9. Residual solvents

Acetone

Ethyl acetate

1896 PPM

795 PPM

NMT 5000 PPM

10. Assay 100.6% 97.5% to 102.0

11. Particle size Complies NMT 90% 10 microns

Gestodene

Gestodene. svg

Gestodeno3D. png

Systematic ( IUPAC) name

( 8R, 9S, 10R, 13S, 14S, 17R) - 13- Ethyl- 17- ethynyl- 17- hydroxy- 1, 2, 6, 7, 8, 9, 10, 11, 12, 14- decahydrocyclopenta[ a] phenanthren- 3- one

Clinical data

AHFS/ Drugs. com International Drug Names

Pregnancy

category

X

Legal status

℞ ( Prescription only)

Routes of

administration oral administration

Pharmacokinetic data

Bioavailability in vitro 99% using 3H=R5020 / in vivo similar to progesterone

Biological half- life 16 to 18 hrs.

Excretion urinary tract mainly

Identifiers

CAS Registry Number 60282- 87- 3 Yes

ATC code G03AA10 G03AB06 ( only combinations with estrogens)

PubChem CID: 3033968

DrugBank DB06730 Yes

ChemSpider 2298532 Yes

UNII 1664P6E6MI Yes

KEGG D04316 Yes

ChEMBL CHEMBL1213583 Yes

Chemical data

Formula C21H26O2

Molecular mass 310.430 g/ mol


Company Contact:


  • Phone: 912406641875

  • Address: PLOT NO: 04 JALGAON ROAD, HARSOOL, AURANGABAD, India

  • Email: Email


Published date: September 8, 2015 -

  • Business Description: We, at SWAPNROOP, are committed to providing affordable Drugs &

    Pharmaceuticals of global quality standards to Pharma Companies all over

    the world. In our warehouse facilities, approved by FDA. we supply

    Pharmaceutical Finished products, Dental products and Active

    Pharmaceutical Ingredients.

    We, at SWAPNROOP, are committed to providing affordable Drugs & Pharmaceuticals of global quality standards to Pharma Companies all over the world. Our warehouse facilities is approved by FDA and we are specializes in sales and marketing of Pharmaceutical Finished products, Pharmaceutical Active Ingredients (API's) and Dental products, providing a wide range of quality and affordable products to a large number of pharmaceutical companies, reputed private and government/semi government organizations/ research centers as well as universities.

    We supply and market over 500 molecules and their combinations in multiple dosage forms, catering to patient needs in various therapies. These include Anti infectives, Cardiovascular, Pain management, Central Nervous System (CNS), Gastrointestinal, Respiratory, Dermatology, Orthopaedics, Nutritionals, Urology and Dental.

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