IP, BP, USP, EP, JP

Complete Pharmacopoeia Monograph Testing (IP, BP, USP, EP, JP)

Every pharmaceutical ingredient must meet the rigorous multi-parameter standards detailed in official monographs. Satvam Research maintains an ever-updating library of pharmacopoeias and reference standards, executing chemical, physical, chromatographic, and microbiological tests to ensure immediate regulatory acceptability.

Standard Turnaround
5 - 7 business days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Compendial Monograph Testing

Satvam Research conducts complete compendial monograph evaluation as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP). From identification, solubility, and melting range to heavy metals, assay, and microbial limits, we deliver authoritative Certificates of Analysis (CoA) for raw materials, excipients, and commercial batch release.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Identification tests: FTIR fingerprinting, UV absorption, colorimetric reactions
Physical constants: Melting point, boiling range, optical rotation, refractive index
Assay and potency: Potentiometric titration, HPLC, GC, non-aqueous titration
Impurities and loss: Loss on drying (LOD), sulfated ash, residue on ignition (ROI)
Heavy metals and limit tests: Chlorides, sulfates, iron, arsenic, ammonium
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

Full Analytical & Spectroscopic Suite - HPLC, GC, FTIR, UV-Vis, Polarimeter, KF Titrator
Shimadzu, Lab India, Mettler Toledo
Model: HPLC, GC, FTIR, UV-Vis, Polarimeter, KF Titrator

Full Analytical & Spectroscopic Suite

Multi-technique compendial verification covering all monograph sections.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

Indian Pharmacopoeia (IP) Current Edition
British Pharmacopoeia (BP) Current Edition
United States Pharmacopeia - National Formulary (USP-NF)
European Pharmacopoeia (Ph. Eur.)
Drugs and Cosmetics Act, 1940 & Rules 1945
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
100 g for bulk powder; sufficient commercial units for finished product monographs.
Container Type
Original manufacturer container or certified clean container with complete labeling.
Storage Condition
As indicated in monograph storage statements.
Standard TAT
5 - 7 business days
Special Instruction: State exact Pharmacopoeia edition and monograph title requested.
Frequently Asked Questions

Technical & Regulatory Inquiries

Do you maintain authenticated pharmacopoeia chemical reference substances?

Yes, we maintain secondary working standards and procure primary official standards (USP, EP, BP, IP) through authorized compendial distributors.

Initiate Your Compendial Monograph Testing Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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