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Biperiden Hcl Usp I Bp Ep Manufacturer - India

price: contact company for price

CERTIFICATE OF ANALYSIS

Product Name Biperiden HCL CAS No:

Batch No: BIP/ 011114 A. R. No 14/ FP/ BIP/ 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 practically odourless crysatalline powder

2. Identification( by HPLC) IR

UV

Chemical test

Chloride test Complies

0.81%

Complies

Complies IR : The IR spectrum of the spl must be concordant with the IR spectrum obtained from biperiden hydroxide WS.

Absorptivities at 257 nm Difference NMT 3.00%

A green colour should produced

Yellow precipitate should be form which does not dissolve on shaking.

A 5 ml portion of a solution responds in the test of chloride.

3. Solubility Complies Slightly soluble in water in ether in alcohol and in chloroform sparingly soluble in methanol.

4. Loss on drying 0.20% NMT 0.50%

5. Ordinary impurities Complies NMT 2.00%

6. Organic volatile impurity

Chloroform

1, 4 dioxane

Methylene chloride

Trichloroethylene

Not detected

BDI

Not detected

NMT 60 PPM

NMT 380 PPM

NMT 600 PPM

NMT 80 PPM

7. Assay 99.89% 98.0% to 101.0%

.

Systematic ( IUPAC) name

( 1RS, 2SR, 4RS) - 1- ( bicyclo[ 2.2.1] hept- 5- en- 2- yl) - 1- phenyl- 3- ( piperidin- 1- yl) propan- 1- ol

Clinical data

AHFS/ Drugs. com monograph

MedlinePlus a699058

Pregnancy

category

AU: B2

US: C ( Risk not ruled out)

Legal status

US: ℞ - only

Routes of

administration Oral, IM, IV

Pharmacokinetic data

Bioavailability 33 ± 5% ( oral)

Protein binding 60%

Metabolism Hepatic hydroxylation

Biological half- life 18 to 24 hours

Excretion Renal

Identifiers

CAS Registry Number 514- 65- 8 Yes

ATC code N04AA02

PubChem CID: 2381

IUPHAR/ BPS 7128

DrugBank DB00810 Yes

ChemSpider 2289 Yes

UNII 0FRP6G56LD Yes

KEGG D00779 Yes

ChEBI CHEBI: 3112 Yes

ChEMBL CHEMBL1101 Yes

Chemical data

Formula C21H29NO

Molecular mass 311.461 g/ mol


Company Contact:


  • Phone: 912406641875

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

  • Email: Email


Published date: September 5, 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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