Sitagliptin Phosphate Monohydrate BP Ph Eur USP IP EP Manufacturers

Search for the supplies that you need here:

ISO-9001-14001-54001 JK Kosher Halal GMP GLP HACCP FSSAI Allergen free Star Export India Gluten free Excipact
FSCC
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).

Sitagliptin Phosphate Monohydrate USP BP Ph Eur IP EP Grade Manufacturers

Anmol Chemicals is a manufacturer supplier exporter of Sitagliptin Phosphate Monohydrate 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.

Synonyms: Sitagliptin Phosphate Monohydrate
CAS Number: 654671-77-9 Monohydrate 654671-78-0 Anhydrous, Molecular Weight: 523.32 Monohydrate, Chemical Formula: C16H20F6N5O6P or C16H15F6N5O•H3PO4-H2O Monohydrate, EINECS EC Number: 682-492-2 Monohydrate 871-227-8 Anhydrous, FEMA: ----,

Sitagliptin Phosphate is the phosphate salt form of sitagliptin, an orally available, competitive, beta-amino acid-derived inhibitor of dipeptidyl peptidase 4 (DDP-4) with hypoglycemic activity. Sitagliptin may cause an increased risk in the development of pancreatitis.

General Properties and Specifications of Sitagliptin Phosphate Monohydrate:
Appearance: White or almost white powder.
Assay: 98% minimum.
Solubility: Soluble in DMSO and in water.
Storage: Refrigerate. OK to freeze. Preserve in a well colsed container.

Sitagliptin Phosphate USP Grade Specifications:
C16H15F6N5O-H3PO4-H2O --- 523.32
C16H15F6N5O-H3PO4 --- 505.31
1,2,4-Triazolo[4,3-a]pyrazine, 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-, phosphate (1:1) monohydrate;
7-[(R)-3-Amino-4-(2,4,5-trifluorophenyl)butanoyl]-3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazine monophosphate monohydrate;
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl-4-(2,4,5-trifluorophenyl)butan-1-on phosphate monohydrate CAS 654671-77-9
UNII: TS63EW8X6F
UNII: QFP0P1DV7Z

DEFINITION
Sitagliptin Phosphate contains NLT 98.0% and NMT 102.0% of sitagliptin phosphate (C16H15F6N5O-H3PO4), calculated on the anhydrous and solvent-free basis.

IDENTIFICATION
A. Infrared Absorption
B. Meets the requirements of the test for Enantiomeric Purity.
C. Identification Tests—General, Phosphate: A solution containing about 40 mg/mL in water meets the requirements of the silver nitrate precipitation tests for orthophosphates.
Organic Impurities: to pass the test by Chromatography.
Water Determination: 3.3% to 3.7%

Sitagliptin Phosphate Monohydrate BP Ph Eur Grade Specifications:
C16H18F6N5O5P,H2O --- 523.3 CASC654671-77-9
Action and use: Dipeptidylpeptidase-4 inhibitor; treatment of diabetes mellitus.

DEFINITION
(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one phosphate monohydrate.
Content: 98.0 per cent to 102.0 per cent (anhydrous substance).

CHARACTERS
Appearance: White or almost white powder.
Solubility: Soluble in water, very slightly soluble in anhydrous ethanol, practically insoluble in heptane.
It shows polymorphism.

IDENTIFICATION
A. Infrared absorption spectrophotometry.
B. Enantiomeric purity.
C. Dissolve 0.200 g in water and dilute to 5.0 mL with the same solvent. The solution gives reaction (a) of phosphates.

Keywords: Sitagliptin Phosphate Monohydrate IP BP Ph Eur EP USP Analytical Reagent FCC Food Grade CAS Number 654671-77-9 Monohydrate 654671-78-0 Anhydrous Manufacturer Supplier Exporter Monograph Uses Chemical Molecular Formula Weight.

ANMOL CHEMICALS
Now maturing as Anmol Chemicals Private Limited
Representatives in Houston, Chicago and New York, USA
TEL: (OFF) +91 22 23726950, +91 22 23774610, +91 22 23723564
Taloja Navi Mumbai, INDIA

Exporters 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. No other use is permitted.