SOP FOR HPLC ANALYSIS AND DOCUMENTATION

1.0   Objective

To describe the procedure to be followed in HPLC analysis and documentation and to insure that good laboratory practices are followed in the HPLC analysis.

2.0   scope

This SOP is applicable for the procedure to be followed in HPLC analysis and documentation and to insure that Good laboratory practices are followed in the HPLC analysis.

CLEANING VALIDATION PROTOCOL FOR PHARMACEUTICALS

1.      Introduction:

The validation of the cleaning procedures is establishing documented evidence that the procedure is effective and capable for removing the contaminants associated with previous products, residues agents as well as the control of potential microbial contaminants.

The cleaning validation is not only ensure the compliance of the regulatory requirements, but a more important benefit for performing cleaning procedure validation is the identification and the correction of the potential problems which could compromise the safety, efficacy or quality of the subsequent batches of drug product.

SOP FOR HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (JASCO)

1.       PURPOSE

        The purpose of this SOP is

1.       To defined the operating procedure.

2.       To define the precautions to be taken during handling.

PREVENTION OF CROSS-CONTAMINATION DURING PROCESSING

       Line clearance should be performed as per SOP & check list and recorded.

·         Check for absence of any starting materials, products, product residues, documents of previous product.

·         Wherever possible adopt “Closed system” while handling materials.

·         Processing of only one material at a time in same cubicle.

SOP FOR BURSTING STRENGTH TESTER

Objective

To provide a procedure for the operation of bursting strength tester.

Scope

Applicable to the bursting strength tester in quality control department.

PRINCIPLE AND CALIBRATION OF ULTRAVIOLET AND VISIBLE ABSORPTION SPECTROPHOTOMETRY

Ultraviolet and visible absorption spectrophotometry is the measurement of the absorption of monochromatic radiation by solution of chemical substances, in the range of 185 nm to 380 nm, and 380 nm to 780 nm of the spectrum, respectively.

The magnitude of the absorption of a solution is expressed in terms of the absorbance, A, defined as the

ATOMIC EMISSION SPECTROMETRY

The technique is used to determine the concentration of certain metallic ions by measuring the intensity of emission of light at a particular wavelength by the vapour of the element generated from the substance. The measurement of the intensity of one of the emission lines of the atomic vapour of the element generated from a solution of that element is the basis of atomic emission spectrometry. The determination is carried out at the

ATOMIC ABSORPTION SPECTROMETRY

This technique is based on the fact that when atoms, ions or ion complexes of an element in the ground state are atomized in a flame, they absorb light at the characteristic wavelength of that element. If the absorption process takes place in the flame under reproducible conditions, the absorption is proportional to the number of absorbing atoms.

SOP FOR CALIBRATION OF HOT AIR OVEN

1.0  OBJECTIVE

To describe the procedure for the calibration of hot air oven

2.0  SCOPE

This SOP is applicable for the calibration of hot air oven.

APPEARANCE OF SOLUTION

Clarity of solution

Standard Suspension

Dissolve 1.0 g of hydrazine sulphate in sufficient water to produce 100.0 ml and set aside for about 6 hour solution add 25.0 ml of a 10.0 per cent w/v solution of hexamine, mix well and allow to stand for 24 hours.