Pharmaceutical

    HPTLC is a flexible and cost-efficient analytical technique. It is used for quality control purposes and to screen for impurities. In addition, HPTLC is used for in-process control and during cleaning validation procedures.

The different analytical tasks in the chemical and pharmaceutical industries include process control during chemical synthesis, quality control and cleaning validation. For all manufacturers of consumer goods, pharmaceuticals, or lifestyle products optimized production processes with minimized interruptions between production cycles are required. Short analysis times allowing short change-over times between different products in the same production unit are therefore in demand. With HPTLC several samples can be analyzed simultaneously and often without or just with a minimal sample preparation. HPTLC is therefore suited as high sample throughput technique at low costs per sample. It also offers the unbeatable advantage to evaluating a plate at any stage of the analytical process and using several detection modes (e.g. UV, fluorescence) in sequence, if required. CAMAG’s instrumental systems are designed to meet the expert’s needs to quantify active ingredients, to successfully analyze various types of impurities in finished products, to control the stage of a production process (in-process control), and to allow clearance of a production unit in a cleaning validation.

HPTLC is the analytical method of choice in a defined cleaning strategy of Sanofi at their API production site in Aramon (France). This approach to clean production vessels and trains can be applied for cleaning of any production plant in any field worldwide and is described in the case study “Cleaning validation at API production units”.

Equip your lab with the CAMAG products that are most suitable for your specific needs and consult with us in the search for the solution to your analytical problems.

Matching CBS articles

HPTLC for stability testing of dihydroartemisinin
CBS 130
pdf
HPTLC – A good technique for extractable and leachable studies of plastics
CBS 130
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Use of TLC, HPTLC, and HPTLC-MS during production and purification processes of active ingredients and their impurities
CBS 129
pdf
Identification and quantification of glucose degradation products
CBS 128
pdf
HPTLC detection of falsification in drugs
CBS 128
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TLC and HPTLC-MS in the manufacturing of clinical API batches
CBS 122
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Degradation profiling of cefixime and azithromycin (antibiotics)
CBS 120
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Cleaning validation at API production units
CBS 114
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Simultaneous determination of pioglitazone, metformine and glimepiride in pharmaceutical preparations
CBS 108
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Rapid test for content uniformity of Coenzyme Q10 in soft gel capsules by HPTLC
CBS 107
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Cleaning validation using HPTLC
CBS 107
pdf
TLC/HPTLC-ELSD-MS coupling
CBS 105
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Validated determination of secoisolariciresinol diglucoside in flaxseed by HPTLC
CBS 104
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Screening for bioactive natural products in sponges
CBS 102
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Use of HPTLC as a problem solving technique in pharmaceutical analysis
CBS 101
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Identification and quantification of amino acids in peptides
CBS 101
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Fast identification of unknown impurities by HPTLC/MS
CBS 101
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Matching methods

ID
Method
A-138.1
Analysis and quality control of lipid-based formulations, e.g. mRNA vaccines, by HPTLC
A-133.1
Quality control of lateral flow test strips by scanning densitometry analysis (e.g. COVID-19)
A-096.1
Rapid content uniformity test of 6 batches of Coenzyme Q10 in soft gel capsules by HPTLC

Case studies

    production unit
    Case Studies
    Yes

    HPTLC offers an inexpensive and time-saving way to control industrial cleaning. The following describes the procedure.