Pharmaceutical excipients can be used in the preparation of dosage forms including tablets, capsules, granules, injections, eye drops, etc., the first three are non-sterile preparations, the latter two are sterile preparations, and the quality of pharmaceutical excipients should be consistent with The corresponding requirements for the applied formulations.

First, the test project

Basic testing: viscosity, residual solvent, heavy metal detection

Excipients for non-sterile preparations: microbiological limit detection

Excipients for aseptic preparation: bacterial endotoxin, sterility test

Second, the corresponding testing items and instrument configuration

1, viscosity

Method: Rotational viscometer method (Pharmacopoeia 0633 method)

Principle: Through a calibrated alloy of bismuth-copper alloy, a rotor is continuously rotated in a liquid sample (such as ethanol). The degree of spring distortion measured by the rotary torque sensor is the torque, which is viscous with the rotor entering the sample. The drag formed by drag is proportional

Instrument configuration: Viscometer

2, residual solvent

Method: Gas Chromatography (Pharmacopoeia 0521 Method)

Instrument configuration: gas chromatograph, ultra pure water machine

3. Heavy metal detection (Pharmacopoeia 0821 method)

Method: Method for detecting heavy metals in ignition residue

Instrument configuration; muffle furnace (500-600 ° C), water bath, single pipette, balance (one ten thousandth), atomic spectrophotometer

4. Microbiological limit inspection of excipients for non-sterile preparations

Method: Microbiological counting method (Pharmacopoeia 1105 method)

Instrument configuration: balance, clean bench, centrifuge, biochemical incubator, low temperature refrigerator, PH meter / acidity meter, high pressure steam sterilizer, microbial limit detector

5, sterile preparations for bacterial endotoxin detection

Method: Gel Limit Method (Pharmacopoeia 1143 Method)

Principle: This method uses sputum reagent to detect or quantify bacterial endotoxin produced by Gram-negative bacteria to determine whether the limit of bacterial endotoxin in pharmaceutical excipients meets the requirements.

Instrument configuration: balance, pipette, vortex mixer, water bath (37+1 ° C), pure water machine

6, aseptic preparation of accessories for aseptic preparation

Method: Membrane filtration method (Pharmacopoeia 1101 method)

Instrument configuration: ultra-clean platform, balance (one ten thousandth), pure water machine, water bath, PH meter, high pressure steam sterilizer, inoculating ring, infrared sterilizer, biochemical incubator, low temperature refrigerator, vortex mixer, Microscope, collection instrument

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