standard testing procedure Carbocisteine syrup
1.0 OBJECTIVE
1.1 To lay down a procedure for analysis of Carbocisteine syrup.
2.0 SCOPE
2.1 This procedure is applicable to the analysis of Carbocisteine syrup. quality control laboratories.
3.0 RESPONSIBILITY
3.1 Q.C- Chemist
4.0 ACCOUNTABILITY
4.1 Manager-Quality Assurance
5.0 PROCEDURE
5.1 Description: Pour 50ml finish sample in beaker and observed visually.
5.2 pH: Taken 50 ml sample in beaker rinse the pH electrode first with purified water followed by sample dip the electrode in sample and observed the pH.
5.3 Volume variation: Measured the volume by measuring cylinder and determine the volume variation.
5.4 Identification:
5.4.1 In the assay, the principle peak in the chromatogram obtain with the test solution correspond to the peak in the chromatogram obtained with the reference solution.
5.5 ASSAY:
Each 5.0 ml contains:
Carbocisteine BP 250 mg.
Mobile phase: Using water and acetonitrile pH 3.0 (90: 10)
Standard preparation: Weight accurately about 250 mg. standard weight of Carbocisteine
diluted to 100 ml volumetric flask with mobile phase. Further dilution 5 ml to 50 ml with mobile phase.
Sample preparation: Taking Weight accurately about 250 mg. Spl of Carbocisteine
diluted to 100 ml volumetric flask with mobile phase. Further dilution 5 ml to 50 ml with mobile phase.
Chromatographic conditions:
Wavelength :220 nm.
Flow rate :1.0 ml /mint.
Injection volume :10 µl.
Column : C18 4.6X 250mm 10 (µm).
6.0 ABBREVIATIONS
| Sr. No. | Abbreviation used | Full form of abbreviation used |
| 1.0 | STP | Standard Testing Procedure |
| 2.0 | QA | Quality assurance |
| 3.0 | STD | Standard |
| 4.0 | SPL | Sample |
| 5.0 | NM | Nano meter |
7.0 REFERENCE
| Sr. No. | Reference Title |
| 01 | In House |
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