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Desmopressin Acetate Usp Ip Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Desmopressin Acetate USP CAS No: 16789- 98- 3

Batch No: DES/ 030313 A. R. No 13/ FP/ DES/ 0303

Date of Manufacture Feb- 2013 Date of Analysis 02- 02- 13

Batch Quantity 165 kg Date of Retest Jan- 2016

Sr. No Test Results Acceptance Criteria

1. Appearance

2. Solubility

3. Identification Complies By HPLC: Retention time of the principle peak in the chromatogram obtained with sample solution should match with that of the principle peak in chromatogram obtained with standard solution.

4. Related Substances

Individual Impurity Total Impurity

0.27 %

1.1%

NMT 0.5%

NMT 1.5%

5. Specific Optical Rotation at 20 0 C ( Anhydrous Basis) - 75º Between - 72° to - 82°

6. Water Content by KF 4.7% NMT 6.0%

7. Assay HPLC 100.91% 95.0% –105.0%

8. Microbial Enumeration Tests 65cfu/ g. NMT 100 cfu/ g.

. .

Desmopressin

Desmopressin. svg

Desmopressin ball- and- stick. png

Systematic ( IUPAC) name

( 2S) - N- [ ( 2R) - 1- [ ( 2- amino- 2- oxoethyl) amino] - 5-

( diaminomethylideneamino) - 1- oxopentan- 2- yl] - 1-

[ ( 4R, 7S, 10S, 13S, 16S) - 7- ( 2- amino- 2- oxoethyl) - 10-

( 3- amino- 3- oxopropyl) - 16- [ ( 4- hydroxyphenyl) methyl] -

6, 9, 12, 15, 18- pentaoxo- 13- ( phenylmethyl) 1, 2- dithia-

5, 8, 11, 14, 17- pentazacycloicosane- 4- carbonyl]

pyrrolidine- 2- carboxamide

Clinical data

Trade names Ddavp, Minirin, Minirin Melt, Octim, Stimate

AHFS/ Drugs. com monograph

Pregnancy

category

AU: B2

US: B ( No risk in non- human studies)

Legal status

UK: Prescription- only ( POM)

US: ℞ - only

Routes of

administration IV, IM, SC, intranasal, oral

Pharmacokinetic data

Bioavailability Variable; 0.08–0.16% ( oral)

Protein binding 50%

Biological half- life 1.5–2.5 hours

Excretion Renal

Identifiers

CAS Registry Number 16679- 58- 6 Yes

ATC code H01BA02

PubChem CID: 5311065

IUPHAR/ BPS 2182

DrugBank DB00035 Yes

ChemSpider 10481973 Yes

UNII ENR1LLB0FP Yes

KEGG D00291 Yes

ChEMBL CHEMBL376685 Yes

Chemical data

Formula C46H64N14O12S2

Molecular mass 1069.22 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 7, 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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