Ampicillin Trihydrate API Manufacturer in Maharashtra, India

Beta-Lactam Penicillin – Manufacturer and Bulk Supplier in Maharashtra for Antibacterial Tablet, Capsule, And Injection Formulations

Ampicillin Trihydrate API Manufacturer and Bulk Supplier in Maharashtra, India – Swapnroop Pharma

Product Specifications

Product Name: Ampicillin Trihydrate API
CAS Number: 7177-48-2
Category: Active Pharmaceutical Ingredient
Grade: Ampicillin Trihydrate 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%

Ampicillin Trihydrate API (CAS No: 7177-48-2)

WHO-GMP Certified Ampicillin Trihydrate API Manufacturer in Maharashtra, India

Ampicillin Trihydrate API (CAS 7177-48-2) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. Swapnroop Drugs and Pharmaceuticals manufactures and supplies Ampicillin Trihydrate API with pharmacopeial compliance (IP/BP/EP/USP as applicable) from our WHO-GMP certified facility in Aurangabad (MIDC Shendra), Maharashtra — one of India's premier pharmaceutical manufacturing zones with robust regulatory infrastructure.

Pharmaceutical formulation companies sourcing Ampicillin Trihydrate API require consistent polymorphic or salt form characterisation, batch-to-batch HPLC purity ≥98% (or per specific pharmacopeial monograph), validated residual solvent control per ICH Q3C, and full impurity profiling against pharmacopeial limits. Our quality control laboratory performs complete pharmacopeial testing with USP/EP/IP validated analytical methods before every batch release.

Swapnroop's Ampicillin Trihydrate API supply is backed by WHO-GMP certified manufacturing, a qualified vendor documentation package (CoA, MSDS, Certificate of Origin, stability data), and dedicated technical support for domestic formulation companies and international export customers. We maintain inventory for rapid order fulfilment across 25+ countries served from our Aurangabad facility.

Key Features

  • HPLC purity ≥98.0% (or per specific IP/BP/USP monograph for Ampicillin Trihydrate)
  • Complete pharmacopeial testing: identification, assay, impurities, LOD, residue on ignition
  • Residual solvent control per ICH Q3C with validated GC/headspace methodology
  • WHO-GMP certified batch with full documentation package for regulatory submissions

Applications

  • Pharmaceutical tablet and capsule formulation development using Ampicillin Trihydrate API
  • Injectable or parenteral formulation programs where Ampicillin Trihydrate is indicated
  • R&D, pilot batch, and commercial manufacturing for domestic and regulated markets
  • Fixed-dose combination (FDC) drug product development programs

Why Choose Swapnroop for Ampicillin Trihydrate?

  • WHO-GMP certified Aurangabad facility with CDSCO-approved manufacturing unit
  • Complete qualified vendor documentation: CoA, MSDS, CoO, stability reports
  • Export capability to 25+ countries with pharmacopeial-grade API
  • Responsive technical support and dedicated account management for long-term buyers

Packaging & Supply

Ampicillin Trihydrate API is supplied in double-polyethylene-lined HDPE drums or fiber drums (25 kg net) with desiccant and nitrogen head-space. Smaller quantities (1 kg, 5 kg) in sealed HDPE jars for R&D programs. All packaging labelled with batch, grade, and pharmacopeial standard.

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Frequently Asked Questions about Ampicillin Trihydrate API

What is the CAS number for Ampicillin Trihydrate API?

The CAS number for Ampicillin Trihydrate is 7177-48-2. It is a Beta-Lactam Penicillin used in pharmaceutical antibacterial tablet, capsule, and injection formulations.

What therapeutic class does Ampicillin Trihydrate belong to?

Ampicillin Trihydrate is classified as a Beta-Lactam Penicillin. It is used in antibacterial tablet, capsule, and injection formulations and is an established API in both domestic Indian and international pharmaceutical markets.

What grades and purity specifications are available for Ampicillin Trihydrate API?

Ampicillin Trihydrate API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, complete related substances profiling, and residual solvent analysis per ICH Q3C guidelines.

What is the minimum order quantity and lead time for Ampicillin Trihydrate 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. Larger volumes may be available from existing stock.

Is DMF-grade documentation available for Ampicillin Trihydrate API?

Yes, Swapnroop provides complete DMF-grade documentation for Ampicillin Trihydrate API including Certificate of Analysis (CoA), MSDS, impurity profile, residual solvent certificate, and regulatory filing support for USFDA, EMA, and CDSCO submissions.

Ampicillin Trihydrate API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Ampicillin Trihydrate API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Ampicillin Trihydrate API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Ampicillin Trihydrate API Exporter from India – Regulatory Filing Support

As a Ampicillin Trihydrate API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Ampicillin Trihydrate API pricing, samples, and sourcing support.