Sitagliptin Phosphate Monohydrate API Manufacturer India

High-Quality Active Pharmaceutical Ingredient for Antidiabetic Formulations

Swapnroop Pharma  ·  WHO-GMP Certified  ·  +91 87670 62101
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Sitagliptin Phosphate Monohydrate API Manufacturer India

Product Specifications

Product Name: Sitagliptin Phosphate Monohydrate API
CAS Number: 654671-77-9
Category: Active Pharmaceutical Ingredient
Grade: IP / BP / EP / USP
Appearance: White to off-white crystalline powder
Standards: IP / BP / EP / USP compliant

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationIR & HPLC compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)2.0 – 4.0
Individual Impurity≤ 0.5%
Total Impurities≤ 1.5%

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WHO-GMP certified · CoA + MSDS included · Ships to 40+ countries

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Sitagliptin Phosphate Monohydrate API (CAS No: 654671-77-9)

High-Quality Active Pharmaceutical Ingredient for Antidiabetic Formulations

Sitagliptin Phosphate Monohydrate is supplied by Swapnroop with a focus on consistent quality control, transparent documentation, and dependable order fulfilment for pharmaceutical buyers.

Buyers sourcing Sitagliptin Phosphate Monohydrate from Swapnroop benefit from a straightforward quotation process, consistent batch-to-batch quality, and responsive technical coordination.

Sitagliptin Phosphate Monohydrate is commonly assessed on quality consistency, handling profile, packaging suitability, and documentation readiness before it is approved for downstream formulation use.

Key Features

  • Flexible order quantities from sampling to commercial scale
  • Quality checks aligned with pharmacopoeial requirements
  • Documentation support aligned with customer qualification needs
  • Batch-to-batch consistency focused for commercial supply

Applications

  • Suitable for regulatory filing support where DMF-grade documentation is required
  • Suitable for formulation development and scale-up studies
  • Used by pharmaceutical buyers seeking consistent raw material supply and documentation coordination
  • Can support commercial procurement, validation batches, and routine production programs

Why Choose Us

  • Consistent commercial communication and responsive quotation support
  • Focus on repeatability, supply continuity, and practical business support
  • Bulk packaging and logistics support for domestic and export dispatch
  • Structured documentation assistance for buyer evaluation

Packaging & Supply

We offer Sitagliptin Phosphate Monohydrate in pharma-oriented packaging formats including HDPE or fiber drum options with inner protection layers, helping maintain handling quality during storage, shipping, and routine supply movement.

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Frequently Asked Questions about Sitagliptin Phosphate Monohydrate API

What is the CAS number for Sitagliptin Phosphate Monohydrate API?

The CAS number for Sitagliptin Phosphate Monohydrate API is 654671-77-9. It is an Active Pharmaceutical Ingredient manufactured by Swapnroop Drugs and Pharmaceuticals in Maharashtra, India.

What pharmacopeial grades is Sitagliptin Phosphate Monohydrate API available in?

Sitagliptin Phosphate Monohydrate API is available in IP, BP, EP, and USP pharmacopeial grades with quality testing per pharmacopoeial and in-house specifications. All batches come with full CoA and MSDS.

What is the MOQ and lead time for Sitagliptin Phosphate Monohydrate API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Expedited supply is available for larger volumes.

Is DMF documentation available for Sitagliptin Phosphate Monohydrate API?

Yes, Swapnroop provides full DMF-grade documentation for Sitagliptin Phosphate Monohydrate API including CoA, MSDS, Genotoxic Impurity Report, Stability Data, and regulatory dossier support for USFDA, EMA, and CDSCO market submissions.

Does Swapnroop export Sitagliptin Phosphate Monohydrate API internationally?

Yes, Swapnroop exports Sitagliptin Phosphate Monohydrate API to 40+ countries including the USA, UK, UAE, Germany, Australia, South Africa, Nigeria, Kenya, Brazil, and Southeast Asian markets. We provide full export documentation and regulatory support.

Sitagliptin Phosphate Monohydrate API Bulk Supplier in India

For companies evaluating Sitagliptin Phosphate Monohydrate API manufacturer options in India, this page offers a clear overview of the product profile, quality approach, and supply readiness.

Sitagliptin Phosphate Monohydrate API Manufacturer for Commercial Sourcing

Our team works with buyers who need Sitagliptin Phosphate Monohydrate API backed by practical documentation support, organized batch handling, and efficient supply communication for ongoing business.