Purpose
This SOP describes
the procedure for preparation and storage of Working Standards.
Scope
This procedure is
applicable to Research and Development Centre ABC Limited
Procedure :
Preparation and Qualification of Working Standards:
- Non-Pharmacopoeial reference standard received in sufficient quantity shall be directly used for routine analysis.
- Raw material for Working Standard preparation shall be selected on following basis:
- Recently manufactured and approved batch, tested as per respective pharmacopoeia/In House specification available in stores.
- Batch of high purity shall be selected for Working Standard.
- For preparation of Working Standard basically two methods are used, as per Pharmacopoeial or by In house method.
- Absolute: Method in which direct analysis is performed. For this no Reference Standard is require like E1%, Potentiometric titration method etc.
- Relative: - In this method reference standard is required to prepare Working Standard like HPLC, UV- Vis- spectrophotometer or gas chromatography.
- In case Reference Standards are not available with the location it shall be procured from authentic source.
- In case, the Reference Standard is not available with the above mentioned, then the Working Standard shall be prepared by analyzing the sample from FDA approved external agency.
- In case, the Reference Standard is not available, then the Working Standard provided by Vender can be used as Reference Standard.
- Perform the following test:
- Description.
- Identification (IR and/or HPLC or as specified in the respective specification if IR or HPLC not mentioned in the respective specification as Id. test).
- Water Content / Loss on drying
- Assay / Potency.
- Related Substances (if Required).
- Any other test specific to the substances.
- Above tests should be carried out as per the Standard Testing Procedure mentioned in respective specification.
- Assay shall be performed in triplicate.
- In the test of Assay prepare one reference standard solution and three Working Standard solution as per the respective Standard Testing Procedure
- System suitability shall be performed, as per respective pharmacopoeia / specification and each Working Standard preparation shall be injected in duplicate.
- The area variation between two injections of individual sample preparation should not be more than 2.0 % of its mean value.
- Calculate the average of 3 assay values obtained on As Is Basis. The RSD of these 3 assay values should not be more than 1.0 %.
- Record the total analytical data in the Protocol.
- Prepare COA for the test performed for the Qualification of Working Standard.
- Validity period of the Working Standard shall be one year from the date of preparation of Working Standard. In case the shelf life of batch selected for Working Standard preparation is less than 1 year then the validity period of Working Standard shall be expiry date of the batch.
- Preserve the Working Standard in clean & dry bottles under controlled Room temperature.
- Prepare fourteen bottles of each material and use single bottle for each month. After completion of 1 month interval discard any material remaining in the bottle and continue with next bottle. On opening of bottle, analyst shall mention the date of opening on the bottle.
- Each bottle should be properly closed and labeled as following format:
- Keep all the bottle of Working Standard in desiccators and as per storage conditions mentioned on the labels.
Storage of working standards:
- Working Standards shall be stored in amber colored bottles closed with PP caps.
- These bottles shall be properly segregated, labeled as per label format and stored.
- Bottles shall be stored as per the storage condition of the material.
- Bottle in use shall be stored in desiccator.
- Silica used in desiccators shall be renewed weekly or whenever the color of silica changes.
Usage and destruction of working standard:
- The Manager shall issue one bottle, to the analyst for its use for not more than one month.
Precautions
- Ensure availability of clean and dry amber color bottles before transferring Working Standard.
- Working Standard shall be stored at temperature, specified on the container label and protected from light.
- Other products shall not contaminate contents of Working Standard bottles or any spoilage should not occur.
- Working Standard bottles shall be immediately closed after use.
