What is the qualification of working standard in Pharma?

Working standards in Pharma are used as a substitute for reference standards that are qualified against the reference standards or the authentic standards. Working standards are materials having high purity. 

Qualification of Working Standards:

To get the qualification of working standards, it is advised to select an approved batch of the current set's respective raw materials. This should contain purity that is well above the lower specified limits for the best results. If the pharmacopoeial reference standard is not available, it is advised to qualify new working standards by comparing it with chemical research laboratories and drug substance manufacturers' standards. If the retesting of existing standards is within the specified limits, then existing-working standards can prepare new working standards for the best results.

The following test is advised during the qualification of working standards.

• Description

• The IR spectrum should be recorded and compared to the reference standard

• Water content test should be performed in triplicate for the best results

• Loss of drying

• Perform assay in triplicate

After the test is done, it is advised to report the assay on an is basis. If the assay of the working standard is above 100%, then it is reported.

Record details of the qualification of working standards such as the batch number, manufacturing date, valid up to and reference standard details. Not just record but also proper documentation of data, including the relevant spectra, reports, and analysis certificate. The complete information is to be determined as to the test methods being employed and the applicable values for each test.

Sometimes, the working standards are not qualified in-house and are being supplied by an external party. In such cases, the results from the certificate of analysis should be adopted and then recorded. This is adopted and recorded in the working standard analytical report.

Working standard numbering:

All working standards are numbered whether it is prepared in-house or supplied by an external party. The procedures of numbering working standards are mentioned below.

You can number the working standards as WS/XXX-SS/YY. In WS stands for working standard, XXX stands for the material defined for the purpose. YY stands for the serial number starting from 01 for each material, and SS stands for the pharmacopoeial standard.

Packing and Storing of Working Standards:

The packing and storing of working standards should be done very cautiously for the best results. You will need to fill an equal quantity of working standards in 13 amber-colored vials following the reverse laminar air flow procedure. From the month of preparation, label each vial with a month. The 13th vial is kept as a control vial and shall be used if necessary. The working standards should be assigned a validity of one year and labeled with the following information mentioned below.

• Name of the working standard

• Month

• Working standard number

• Valid up to

• Date of qualification

• Assay

• Storage condition

The storing of the working standards is also very important. Ensure that the working standards are stored at the prescribed storage condition. The best-recommended storage condition varies from 2 degrees to 8 degrees.

Article source: https://article-realm.com/article/Sports-Recreation/10573-What-is-the-qualification-of-working-standard-in-Pharma.html