IP, BP and USP are pharmacopoeias: official books of quality standards for medicines and their ingredients. IP is the Indian Pharmacopoeia, the legal standard in India; BP is the British Pharmacopoeia; USP is the United States Pharmacopeia. A chemical sold as "IP grade" meets the Indian monograph for that substance. Specify the standard and its edition, never just "pharma grade".
Reading IP, BP or USP on a tablet strip or syrup label? See what IP, BP and USP mean on medicine labels. This guide is written for manufacturers and buyers.
If you manufacture or procure chemicals for pharmaceutical, food, or regulated industrial use in India, you have almost certainly encountered the designations IP, BP, USP, or NF on a Certificate of Analysis. These are pharmacopoeial grade references — and they are not interchangeable. Nor is the phrase "pharma grade" a valid substitute for any of them.
This guide explains what each standard means, which regulatory bodies recognise each, which to specify for your application, and what Supreme Petro Chemicals supplies across these grades.
What Is a Pharmacopoeia?
A pharmacopoeia is an officially recognised compendium of quality standards for medicinal substances — active ingredients, excipients, dosage forms, and reagents. For each listed substance, it specifies identity tests, assay methods, purity requirements, impurity limits, and acceptance criteria. Regulatory agencies and GMP auditors treat pharmacopoeial compliance as the minimum quality baseline for pharmaceutical-grade material.
Pharmacopoeias are updated regularly through addenda and new editions. A CoA referencing an outdated edition may not satisfy current GMP requirements — always confirm the edition cited against what your QA system specifies.
IP — Indian Pharmacopoeia
Published by the Indian Pharmacopoeia Commission (IPC), Ghaziabad, under the Ministry of Health and Family Welfare. Current edition: IP 2026, the 10th edition, released on 2 January 2026 with 3,340 monographs, 121 of them new. It supersedes IP 2022, but an IP 2022 monograph that is absent from IP 2026 remains official.
IP is the legally recognised standard under the Drugs and Cosmetics Act, 1940. Any drug substance or pharmaceutical-grade excipient manufactured or marketed in India for domestic use must comply with IP monographs where they exist. Since October 2023 the IPC has been a full member of the Pharmacopoeial Discussion Group (PDG), alongside the European, Japanese and US pharmacopoeias. In IP 2026, 18 general chapters and 22 excipient monographs are harmonised with PDG texts. Harmonised means the same test result and the same accept/reject decision, not identical legal status, so IP remains the legal standard for products made for the Indian market.
For procurement teams: specifying IP grade is the correct starting point for any chemical entering an Indian-market pharmaceutical formulation.
BP — British Pharmacopoeia
Published annually by the Medicines and Healthcare products Regulatory Agency (MHRA), UK. In force now: BP 2026, legally effective from 1 January 2026. BP 2027 takes effect on 1 January 2027.
BP incorporates monographs from the European Pharmacopoeia (Ph.Eur) by reference, which means BP compliance effectively implies Ph.Eur compliance for most monographed substances. BP is the primary reference for UK, Commonwealth countries, Gulf and Middle Eastern markets, and much of South-East Asia.
In India, BP grade is widely accepted alongside IP for pharmaceutical procurement — particularly in export-oriented manufacturing and in plants operated by multinational pharmaceutical companies. Many Indian pharma companies specify BP as their procurement standard because it aligns with both domestic IP requirements and export market needs.
USP — United States Pharmacopeia
Published by the United States Pharmacopeial Convention as the combined USP–NF (United States Pharmacopeia – National Formulary). Since July 2025 USP–NF is published online as six issues a year, and each monograph carries its own official date, so there is no single "USP 2026" edition. A CoA should cite the monograph's official date or the USP–NF issue it was tested against.
USP is the reference standard recognised by the US Food and Drug Administration (FDA). For any chemical entering a US-market drug product — whether as an active ingredient, excipient, or processing solvent — USP or NF compliance is required. USP is also the de facto global standard for multinational pharmaceutical supply chains because of the FDA's reach and the broad international adoption of its monographs.
For Indian manufacturers operating USFDA-approved facilities or supplying US-market finished dosage forms, USP or NF grade with full batch CoA from the original manufacturer is non-negotiable.
NF — National Formulary
The NF is published as part of the combined USP–NF volume and covers excipients specifically — substances used as carriers, diluents, binders, solvents, humectants, and processing aids in pharmaceutical formulations. When a chemical is designated "NF grade", it means it complies with the NF monograph for that excipient.
The practical distinction: APIs and drug substances generally have USP monographs; excipients generally have NF monographs. Propylene glycol, polyethylene glycols, sorbitol, glycerine, and similar excipients are monographed in NF. Specifying "USP/NF grade" for an excipient is technically more precise than "USP grade" alone.
Ph.Eur — European Pharmacopoeia
Published by the European Directorate for the Quality of Medicines (EDQM), Council of Europe. In force now: the 12th edition (published in mid-2025, online only), with issues 12.1, 12.2 and 12.3 implemented on 1 January, 1 April and 1 July 2026. Issue 13.1 takes effect on 1 January 2027.
Ph.Eur is the regulatory reference for the European Medicines Agency (EMA) and all EU national regulatory bodies. Because BP incorporates Ph.Eur monographs by reference, a material that meets BP typically also meets Ph.Eur. For Indian exporters to the European market or those holding EU-GMP certificates, Ph.Eur compliance may need to be explicitly confirmed on the CoA — not simply assumed from BP compliance.
JP — Japanese Pharmacopoeia
The official pharmacopoeia of Japan, published by its Ministry of Health, Labour and Welfare. The 19th edition (JP 19) was published on 10 April 2026 and took effect immediately; its transition period ends on 30 September 2027. JP is one of the four PDG pharmacopoeias and matters to Indian exporters supplying the Japanese market.
FCC / FFG — Food Grade
FCC stands for Food Chemicals Codex, published by USP. It sets purity and identity standards for chemicals used in food processing, flavouring, and preservation. The current edition, FCC 15, took effect on 1 June 2026. In Indian commercial practice, the term FFG (Food/Feed Grade) is commonly used for chemicals supplied to food and animal feed applications.
Food grade is not a pharmacopoeial standard. It is governed by FSSAI (Food Safety and Standards Authority of India) for the Indian market, and by the FDA or EFSA for US and EU food applications. A CoA marked "food grade" or "FCC" does not imply pharmaceutical compliance — the two standards have different test parameters and impurity limits. Never use food-grade material in pharmaceutical manufacturing without explicit QA approval and grade verification.
Standards at a Glance
| Standard | Publisher | Primary Market | Indian Pharma Use |
|---|---|---|---|
| IP | Indian Pharmacopoeia Commission | India (legally mandated) | Domestic pharma, Schedule M GMP compliance |
| BP | MHRA, UK (annual) | UK, Commonwealth, Gulf, SE Asia | Export manufacturing, MNC procurement benchmark |
| USP | USP Convention, USA | USA, global supply chains | USFDA-approved facilities, US-market export |
| NF | USP Convention (USP–NF) | USA | Excipient specification for US-market products |
| Ph.Eur | EDQM, Council of Europe | European Union | EU-GMP plants, EMA submissions |
| JP | Ministry of Health, Labour and Welfare, Japan | Japan | Export to Japan |
| FCC / FFG | USP / FSSAI | Food and feed applications | Food processing, FSSAI-licensed manufacturing |
Which Grade to Specify — Practical Decision Guide
Manufacturing for the Indian domestic pharma market
Specify IP grade as the primary requirement. BP is broadly accepted as equivalent for monographed excipients, subject to your QA team's approval. "Pharma grade" without a pharmacopoeial reference is not acceptable under Schedule M GMP.
Manufacturing for UK, Middle East, or Commonwealth export
Specify BP grade. Confirm that the CoA cites the current BP edition and covers all relevant monograph parameters. For EU export, verify Ph.Eur compliance explicitly on the CoA — do not assume BP implies Ph.Eur without confirmation.
Manufacturing for USFDA-inspected plants or US-market products
Specify USP or NF grade depending on whether the substance is an API (USP) or excipient (NF). The CoA must reference the current USP–NF edition. For critical excipients, a Drug Master File (DMF) or CEP may also be required.
Food, flavouring, or FSSAI-licensed manufacturing
Specify FCC or food grade with FSSAI-compliant documentation. Do not assume pharma grade implies food-grade compliance — they are separate standards with different impurity profiles and test requirements.
Why "Pharma Grade" Alone Is Not a Valid Specification
In India's chemical trading market, "pharma grade" is widely used as a marketing label with no enforceable meaning. It could describe a genuine IP-certified batch from a licensed manufacturer with a complete CoA — or a standard technical product relabelled by a trader. For GMP compliance, the CoA presented to your QA team must state:
- The specific pharmacopoeial reference and edition (e.g., IP 2026, BP 2026, or the official date of the USP–NF monograph)
- The batch number and manufacturing date
- Numeric test results for each pharmacopoeial parameter (assay, water content, heavy metals, residue on evaporation, specific impurities)
- The name and registered address of the original manufacturer
Without all four, the CoA is not GMP-compliant regardless of how the grade is labelled on the drum.
Chemicals SPC Supplies in Pharmacopoeial Grades
Supreme Petro Chemicals maintains stock of the following chemicals in IP, BP, and/or USP grades. Available grade depends on current stock and manufacturer. State your required standard and pharmacopoeial edition at the time of enquiry.
- Propylene Glycol (CAS 57-55-6) — IP / BP / USP grade. Excipient, humectant, co-solvent in oral, topical, and parenteral formulations.
- Isopropyl Alcohol / IPA (CAS 67-63-0) — IP / BP / USP grade. GMP equipment cleaning, surface sanitisation, excipient in topical and oral preparations.
- Glycerine / Glycerol (CAS 56-81-5) — IP / BP / USP grade. Humectant, solvent, co-solvent, excipient across oral, topical, and suppository formulations.
- Benzyl Alcohol (CAS 100-51-6) — IP / BP grade. Antimicrobial preservative in injectable and topical preparations; pharmaceutical solvent.
- Sorbitol (CAS 50-70-4) — IP / BP / USP / NF grade. Excipient in syrups, chewable tablets, and parenteral nutrition solutions.
- Sodium Benzoate (CAS 532-32-1) — IP / BP / USP grade. Antimicrobial preservative in liquid oral formulations.
- Citric Acid Anhydrous (CAS 77-92-9) and Monohydrate (CAS 5949-29-1) — IP / BP / USP grade. Buffer agent, acidulant, chelating agent in pharmaceutical formulations.
- Boric Acid (CAS 10043-35-3) — IP / BP grade. Ophthalmic preparations, antiseptic formulations.
- Acetic Acid Glacial (CAS 64-19-7) — BP / USP grade. Buffer preparation, pH adjustment, pharmaceutical synthesis intermediate.
- Polyethylene Glycol / PEG grades (CAS 25322-68-3) — BP / NF grade depending on molecular weight. Tablet excipient, capsule lubricant, topical base, suppository vehicle.
This shortlist covers the excipient head. The complete list — every food and pharma grade line we hold across solvents, glycols, waxes, surfactants, acids, polyols and excipient powders, each with grade, CAS number, standard packing and approved makes — is published on our Food & Pharma Grade Chemicals stock list, with a downloadable PDF.
FAQ
What are the full forms of IP, BP and USP?
IP is the Indian Pharmacopoeia, BP the British Pharmacopoeia and USP the United States Pharmacopeia. Related abbreviations: NF is the National Formulary (published with USP), Ph. Eur. the European Pharmacopoeia, JP the Japanese Pharmacopoeia and FCC the Food Chemicals Codex.
Is IP grade equivalent to BP grade?
Often close, but not automatically. The IPC harmonises texts with the European, Japanese and US pharmacopoeias through the PDG, and BP incorporates European Pharmacopoeia monographs, so for many excipients the requirements are similar. Test methods, reference standards and specific impurity limits can still differ. Document which standard was tested — do not assume interchangeability without your QA team's confirmation for the specific substance and application.
Can BP grade be used for an IP-regulated product in India?
In Indian practice, BP grade is widely accepted as equivalent to IP for most excipients, subject to QA approval and documented justification in your material specification. Your internal SOP and regulatory affairs team should govern this — not the supplier's assurance.
What if a chemical doesn't have an IP monograph?
If no IP monograph exists for a substance, BP or USP grade is typically accepted under Indian GMP guidelines, provided the relevant pharmacopoeial standard is documented in your Material Specification and approved by QA.
Related grade guides
| Guide | Read it for |
|---|---|
| What does IP mean on a tablet? | What IP, BP and USP mean on medicine labels |
| What does "USP grade" mean? | USP vs NF vs FCC vs ACS, and what a USP-grade claim must be backed by |
| DEG and EG testing for glycerine, PG, sorbitol and PEG | What Indian regulators have asked for on diethylene and ethylene glycol testing of excipients |
| IPA grades and uses | Industrial vs IP/BP/USP isopropyl alcohol |
| Propylene glycol USP grade | Pharma applications and what to specify |
| Glycerine grades | Pharma, cosmetic and industrial glycerine |
| Food-grade chemicals and FCC | Food-grade standards and buying checks |
| Boric acid grades | Technical, pharma and agricultural grades |
| Benzyl alcohol uses and grades | Preservative and solvent grades |
| Acetic acid grades | Industrial, food and pharma acetic acid |
| How to read an SDS | The safety data sheet, section by section |
| CAS number reference | Verified identifiers for common chemicals |
Request Pharmacopoeial Grade Material
For IP, BP, USP, or NF grade chemicals with full batch CoA, contact Supreme Petro Chemicals or WhatsApp an enquiry. Provide the chemical name, CAS number, required pharmacopoeial standard, quantity, packaging preference, and any specific CoA parameters your QA team requires. We supply from Chennai to pharmaceutical manufacturers across South India.
Last reviewed 3 October 2026. Changes: editions updated to IP 2026, BP 2026 (BP 2027 from 1 January 2027), the Ph. Eur. 12th edition and the USP–NF online publication model; added JP 19 and FCC 15; harmonisation wording corrected to the published PDG facts; added the related grade guides.