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FSCC 22000
Food Safety Systems Certification
cGMP, GLP - FDA Approved, ISO 9001, ISO 14001, ISO 17025, ISO 45001, HACCP, FSSC 22000, FSSAI, "REACH" Registered, Kosher & Halal Certified. We observe WHO Good Manufacturing Practice GMP and Good Laboratory Practice GLP
Excellence in Excipients and API Manufacturing.DMF Support and Documentations Available
WHO-GMP Certified
Good Manufacturing Practice Certified by World Health Organization
WC, Written Confirmation
for Active Substance to be imported into European Union (EU).Perindopril Tert-Butylamine or Perindopril Erbumine BP Ph Eur USP EP Grade Manufacturers
Anmol Chemicals is a manufacturer supplier exporter of Perindopril Tert-Butylamine or Perindopril Erbumine BP Ph Eur USP EP Grade and it offers materials as per IP BP EP Ph Eur USP NF JP FCC Food Grade as per the the latest monograph at best prices. Anmol Chemicals Group, established in 1976, is the pioneer manufacturer of Specialty Chemicals, Pharmaceutical Excipients, Some API, Food Chemicals in India. Anmol Chemicals Group has manufacturing facilities spread across Western India, representatives in Houston, Chicago USA and Dubai, UAE. We also have toll manufacturing units for processing chemicals in a few countries around the world. We make IP, BP, EP, USP, NF, Ph. Eur., JP, FCC or Food Grade, Analytical Reagent Grade, LR or Laboratory Reagent Grades and Pure Grades of various chemicals. All our items are analyzed to meet the required standards. We can supply the product in grams for your laboratory trial and in tons for your plant scale jobs.
We manufacture Bulk Drugs / API, Excipients, Pharmaceuticals (IP BP USP NF Ph Eur EP JP), Specialty Chemicals (Pure/Reagent), Mineral Fortifiers (FCC). Our manufacturing facility is FDA approved and GLP, cGMP, ISO9001, ISO14001, ISO/IEC 17025, ISO22000, FSSC 22000, ISO45001, FSSAI, Kosher, HALAL, COPP, WHO-GMP certified and Written Confirmation (WC) is available. Solid materials can be customized for particle size, shape, and bulk density. We observe WHO Good Manufacturing Practices and Good Laboratory Practices. We are a government-recognized STAR Export House and "Authorised Economic Operator (AEO)" per Indian Customs.
All technical documents and DMF support available.
Perindopril Tert-Butylamine or Perindopril Erbumine SDS of Manufacturers
Synonyms: Perindopril Tert-Butylamine or Perindopril Erbumine
CAS Number: 107133-36-8, Molecular Weight: 441.6, Chemical Formula: C19H32N2O5-C4H11N, EINECS EC Number: 600-798-6, FEMA: NA,Perindopril tert-butylamine also commonly known as perindopril erbumine is a prescription medication belonging to a class of drugs called angiotensin-converting enzyme (ACE) inhibitors. It is primarily used to treat high blood pressure (hypertension), manage heart failure, and lower the risk of cardiovascular events like heart attacks in individuals diagnosed with stable coronary artery disease.
General Properties and Specifications of Perindopril Tert-Butylamine or Perindopril Erbumine:
Appearance: White or almost white, slightly hygroscopic, crystalline powder.
Assay: 99% minimum.
Melting Point: 126C to 128C literature.
Solubility: Freely soluble in water and in ethanol (96 per cent), soluble or sparingly soluble in methylene chloride.
Storage: In an airtight containers at controlled room temperature.Perindopril Erbumine USP Grade Specifications:
C19H32N2O5-C4H11N --- 441.6
1H -Indole-2-carboxylic acid, 1-[2-[[1-(ethoxycarbonyl)butyl]amino]-1-oxopropyl]octahydro-, [2S-[1[R*(R*)],2α,3aβ,7aβ]]-, compound with 2-methyl-2-propanamine (1:1);
(2S ,3aS ,7aS)-1-[(S)-N-[(S)-1-Carboxybutyl]alanyl]hexahydro-2-indolinecarboxylic acid, 1-ethyl ester, compound with tert-butylamine (1:1);
(2S ,3aS ,7aS )-1-{(S)-2-[(R)-1-Ethoxy-1-oxopentan-2-ylamino]propanoyl}octahydro-1H -indole-2-carboxylic acid
CAS 107133-36-8
UNII: 1964X464OJ
UNII: Y5GMK36KGYDEFINITION
Perindopril Erbumine contains NLT 98.0% and NMT 102.0% of perindopril erbumine (C19H32N2O5-C4H11N), calculated on anhydrous basis.IDENTIFICATION
A. Infrared Absorption.
B. The retention time of the major peak of the Sample solution corresponds to that of System suitability solution 1, as obtained in the test for Limit of Perindopril Related Compound I.
Residue on Ignition: NMT 0.1%
Organic Impurities: To pass the test by chromatography.
Limit of Perindopril Related Compound A and Imidazole: To pass the test by chromatography.
Water Determination: NMT 1.0%; 3.00%–4.50% for a monohydrate.
Optical Rotation, Specific Rotation: Sample solution: 10 mg/mL of Perindopril Erbumine in ethanol. Acceptance criteria: −66° to −69°, at 20C.
Packaging and Storage: Preserve in tight containers at controlled room temperature.
Perindopril Erbumine BP Ph Eur Grade Specifications:
C23H43N3O5 --- 441.6 CAS 107133-36-8
Action and use: Angiotensin converting enzyme inhibitor.DEFINITION
2-Methylpropan-2-amine (2S,3aS,7aS)-1-[(2S)-2-[[(1S)-1-(ethoxycarbonyl)butyl]amino]propanoyl]octahydro-1H-indole-2-carboxylate.
Content: 99.0 per cent to 101.0 per cent (anhydrous substance).CHARACTERS
Appearance: White or almost white, slightly hygroscopic, crystalline powder.
Solubility: Freely soluble in water and in ethanol (96 per cent), soluble or sparingly soluble in methylene chloride.IDENTIFICATION
A. Specific optical rotation: -69 to -66 (anhydrous substance). Dissolve 0.250 ;g in ethanol (96 per cent) and dilute to 25.0 mL with the same solvent.
B. Infrared absorption spectrophotometry.
C. Examine the chromatograms obtained in the test for impurity A.TESTS
Impurity A: To pass the test by Thin-layer chromatography.
Stereochemical purity: To pass the test by Liquid chromatography.
Related substances: To pass the test by Liquid chromatography.
Water: Maximum 1.0 per cent, determined on 0.50 g.
Sulfated ash: Maximum 0.1 per cent, determined on 1.0 g.
Storage: In an airtight container.Perindopril Tert-Butylamine or Perindopril Erbumine EP Grade is also manufactured as per monograph.
Keywords: Perindopril Tert-Butylamine or Perindopril Erbumine IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 107133-36-8 Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.
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Manufacturer Supplier Exporter
ANMOL CHEMICALS Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 65290102, +91 22 65290103
Taloja Navi Mumbai, Banglore, INDIAe-mail: info@anmol.org
Copyright and Usual Disclaimer is Applicable
Last updated 1-jun-26Exporters to USA, Canada, UAE, Kuwait, Qatar, Gautemala, Tunisia, Europe, South Africa, Bangladesh, Sri Lanka, Tanzania, Kenya, Egypt, Iraq, Turkey, Israel, Vietnam, Nigeria, Uganda, Brazil, Chile, Argentina, Dubai, UAE, Saudi Arabia, Cameroon, Mexico, Brazil, Chile, Argentina, Korea, Thailand, Malaysia, Indonesia, Jakarta, Australia, China, Germany, France, etc.
Representatives in New York, Houston - Texas, Chicago - Illinois, Los Angeles.
All products are Sold for Industrial and Laboratory Use only.
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Perindopril Erbumine BP Ph Eur EP USP Grade Manufacturers