Handling & use of IPRS
IPRS are not intended for administration to human or animals as drugs or medical devices. They are intended for test and assay use only as per Indian Pharmacopoeia. IPRS should be used immediately after opening, any unused portion of the IPRS may be stored and reused is the sole responsibility of the user.
For effective use of IPRS following points may be followed:
1. If the IPRS is stored at low temperature, allow it to reach room temperature before opening the vial.
2. To eliminate any static inside the vial, tap the vial prior to removing the stopper or use an anti-static device.
3. Minimize handling steps. Weigh the material directly into the volumetric flask or other laboratory glassware being used to prepare the solution. This will reduce the risk of losing material due to static.
4. A spatula with an angled point may be more effective than the typical weighing spatula.
Storage of IPRS
IPRS should be stored between 2˚C to 8˚C.
Certificate of Analysis
Indian Pharmacopoeia Commission does not provide certificate of analysis (COA) for IPRS. For the analysis purpose, the assay value content (on as is basis) of the reference substances is provided on the label of IPRS.
No expiry date is given on the label of the IPRS. The IPRS is valid for use until it appears on the IPC website www.ipc.gov.in as current lot number. The current lot number is always listed on the website. The validity of the previous lot is mentioned as the subscript of the previous lot number on the website. IPRS retested regularly to confirm it’s continued suitable for use.
Procurement of IPRS
Find your requirement of IPRS as per the list available on the IPC website. Download supply order form from the website, fill it completely and send your completed supply order form along with demand draft to the following address.
Secretary-cum-scientific-Director, Indian Pharmacopoeia Commission, Ministry of Health & Family Welfare, Government of India, Sector-23, Raj Nagar, Ghaziabad, India-201002.
For procurement of more than 2 vials of a single IPRS, stakeholders are advised to check the availability by contacting IPC by email, by fax, or by telephone.
Note: The process for IPRS supply will only be start after receiving the demand draft of required amount, in original.