Pharmaceutical Guidance Complete Pharma Solution
- Objective:To lay down a procedure for preparation and standardization of volumetric solution.
- Scope:This SOP is applicable for preparation and standardization of volumetric solution in quality control laboratory in pharmaceutical company name with location.
- Responsibility:
- Officer or above of QC Laboratory is responsible for follow the procedure mentined in this SOP.
- Accountability:Head QC and QA shall be accountable for compliance of SOPs.
- Abbreviations and Definitions:
- VS:Volumetric solutions
- RSD: Relative Standard Deviation
- Procedure:
- Volumetric solutions, known also as Standard Solutions, are solutions of reagents of known concentration intended primarily for use in quantitative determinations. Concentrations are usually expressed in terms of normality.
- Volumetric solution preparation:
- Prepare Volumetric solution of specific strength, wherever applicable,as per procedure given in appendix of Pharmacopoeia.
- Volumetric solutions should not be differ from the prescribed strength by more than 10% and the Normality /Molarity should be determined in triplicate and so that RSD below 1.0 %.
- For the preparation of dilute Normal and Molar solution, if required, solution of standard Normality / Molarity may be diluted in exact proportion and same shall be used, and should be re-standardized either as directed for the primary standards or by comparing with other volumetric solutions having a known concentration.
- When a solution is used in an assay in which the end point is determined by an electrochemical process (potentiometrically) the solution must be standardized in the same way.
- Volumetric solution shall be used within one month of preparation. Incase of any unusual observation, (Crystallization, sedimentation, Haziness and decolourisation) it shall be discarded.
- Assign Sr number for volumetric solutions as follows
- VS/XX/YY
- Where
VS : stand for volumetric solutions
XX : stand for serial number
YY : stand for year
- To ensure the stability of the volumetric solution, check the Normality and Molarity of the solution in triplicate at once in every 5 days for one month and record the same. The RSD of the all observations must be in 1.0 %.
- Standardization: Normality and Molarity determine in triplicate. The average of the three titration shall be considered for calculation. Record raw data in Logbook.
- Make entry for Volumetric Standard Solution Logbook.
- Re-standardization shall be done once in fortnightly.
- After preparation & standardization of Volumetric solutions, paste the Label on the respective glass bottles and storage as per specified requirement or room temperature.
- Forms and Records (Annexures)
- Preparation and standardization of volumetric solution logbook-Annexure -I
- Distribution
- Master copy – Quality Assurance
- Controlled copies – Quality Assurance & Quality Control
- History
| Date | Revision Number |
Reason for Revision |
| – | 00 | New SOP |
Annexure -I
Preparation and Standardization of volumetric solution Logbook
| Date of preparation | B.No of Primary Stand | Date of
Standardization |
Wt.of primary standandard | Burette Reading/ Normality / Molarity | Mean Normality/ Molarity | Valid
up to |
Prepared by | Checked by |
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube
