IP Grade (Indian Pharmacopoeia) chemicals

What the grade means

IP grade material complies with its monograph in the Indian Pharmacopoeia, published by the Indian Pharmacopoeia Commission under the Ministry of Health and Family Welfare. Its standards carry legal force under the Drugs and Cosmetics Act, 1940 and its rules, and new editions and addenda appear periodically.

What a monograph controls

• Definition and content limits, often on the dried or anhydrous basis.
• Identification by IR, HPLC or chemical tests.
• Related substances, residual solvents, heavy metals or elemental impurities, sulfated ash and water or loss on drying.
• Assay by a stated method, plus storage and labelling.

Sodium chloride IP, for example, requires 99.0 to 100.5 percent content on the dried basis and loss on drying of 0.5 percent at most.

When to choose it

Choose IP grade for medicines made or sold in India and for any buyer whose regulator accepts IP. Many exporters ask for dual IP and BP or USP compliance, which the COA states.

Documentation

Each lot ships with a COA naming the IP edition, and a GHS SDS. Products with pharmacopoeial grades are listed in APIs.