Services


Our Services

Analog Labs is a full service environmental laboratory providing clients with an extensive array of specialty analytical testing services. Our state of the art facilities and equipment allow us to increase project efficiency and provide high quality data and service as per the specification and requirements of a wide range of organic, inorganic, pharmaceutical clients. Our laboratory for analytical testing provides the one stop solution and comprehensive analytical support for organic, inorganic, and biological laboratory services.

Our all encompassing range of analytical testing services, synthesis and regulatory support are from a single source. The highlighting features of our analytical services includes: Expert impurity identification Thorough testing of drug substance or drug product by Qualified Person Special and reliable technique is employed.

The following are the categories of the services we provide :

Certified Training Course on Analytical instrumentation (HPLC, GC, Spectroscopy, Dissolution etc.,) & Chemical Analysis

We offer to our customers new extremely flexible and reliable HPLC testing service. The new HPLC facility is GLP compliant and has state-of-the-art instrumentation, including Agilent and Beckman System Gold HPLC stations with UV, Fluo and DAD detectors. We do routine HPLC testings and develop HPLC methods for our clients. Large collection of HPLC columns allows fast metod development. We invite our customers to place orders for HPLC testings on our high capacity GLP compliant HPLC facility.

Pharmaceutical API, Drug Substances, Excipients and Raw Materials Testing

An active ingredient (AI), is the substance in a pharmaceutical drug or a pesticide that is biologically active. Terms in similar use include: active pharmaceutical ingredient (API) and bulk active in medicine, or in pesticide formulations active substance may be used. Some medications and pesticide products may contain more than one active ingredient. The traditional word for the API is pharmacon or pharmakon (from Greek: (f??Ua???), adapted from pharmacos) which originally denoted a magical substance or drug.

A dosage form of a drug is traditionally composed of two things: The API, which is the drug itself; and an excipient, which is the substance of the tablet, or the liquid the API is suspended in, or other material that is pharmaceutically inert. Drugs are chosen primarily for their active ingredients.

We provide a range of standard and customised analyses for pharmaceutical raw materials and intermediates. Our group of dedicated scientists and technologists provide compendial or client based routine raw materials testing services with capabilities covering raw materials, active pharmaceutical ingredients, excipients and finished products.

Our raw materials testing service can be scaled to your requirements so we can carry out all routine analysis for your products or act in partnership with your own facilities. We understand the importance of getting the job done quickly to minimise any hold-ups in manufacturing, and enable more efficient stock planning.

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Pharmaceutical Quality Control & Finished Product Release Testing

Analog Labs offers comprehensive QC and release testing for Active Pharmaceutical Ingredients (APIs), pharmaceutical intermediates, excipients and finished products. Our analytical laboratories provide release testing of in-process materials as well as finished products. Whether you need results overnight or next week, we have the capabilities to meet your most demanding turnaround time requirements.

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Pharmaceutical Method Development and Validation

We have extensive experience in the development of analytical methods for pharmaceutical drug substances and products. We routinely work on a wide range of formulation types and on projects which involve analysing a variety of compound types at all stages of development. Our involvement can range from developing a new method to updating an existing one. Our wide-ranging experience has led to the development of innovative analytical solutions in our accredited laboratories.

Our analytical capability is regularly extended and developed to meet our clients' requirements. We work with our clients to increase their available resource, decrease the potential for delays in their development programmes and provide an independent validation.

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Physical Chemical Properties Testing

Coming Soon!

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Limits Testing

We offer excellent solutions for Limits Testing (MLT).

 

The Quantitative phase of testing determines the bioburden of given pharmaceutical manufacturing samples, determining the number of total aerobic organisms as well as the total number of yeasts, and molds.

The first step in Microbial limits testing is the preparatory testing which validates the product with the method used. This ensures the product has no inhibitory effect on the recovery of organisms from the product. Once the product has passed the Preparatory Test, the product is validated for routine screening. The routine Microbial limits screening test consists of the total aerobic and total yeast and mold counts as well as the test for objectionable microorganisms. If the total aerobic and total yeast and mold counts are acceptable and no objectionable organisms are found, Microtest then gives the "go-ahead" for swift release of the product or raw material.

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Ultraviolet Absorption Testing

UV/VIS Spectrophotometry is used to determine the absorption or transmission of UV/VIS light by a sample. It can also be used to measure concentrations of absorbing materials based on developed calibration curves of the material. A sample is placed in the UV/VIS beam and a graph of the transmittance or absorbance versus the wavelength is obtained.

Alternatively, samples are prepared in known concentrations and their absorbance is read by the UV/VIS Spectrophotometer. Results are then graphed to make a calibration curve from which the unknown concentration can be determined by its absorbance.

A spectrum of percent transmittance or absorbance versus wavelength. The concentration can be found by mathematical methods based on Beer's Law

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Pharmaceutical Microbiology Testing

We specialize in microbiology testing to support production quality control programs. We have experience in microbiology QC provide expertise and confidence in the accuracy of your test data. Bacterial isolates are identified using our powerful validated DNA Sequencing Service. Fungal isolates are identified by our staff mycologist and by our DNA sequencing services. Our microbiology laboratory is a team of experienced professionals specializing in several standard tests. Specialist Microbiological method development and validation (sterile and non-sterile products). Sterility Testing using isolator technology with VHP sterilisation. Bacterial Endotoxin (LAL) Testing - Gel Clot/Kinetic Turbidimetric & Chromogenic Bioburden analysis - Absence of & Total Viable Counts. Microbial identification - DNA/API System & API lab software. Preservative Efficacy Testing. Stability testing support for API and finished products.

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Pharmaceutical Compendial Testing (IP.USP, JP, BP, PhEur)

Analog Labs, performs a vast array of tests from a variety of compendia. These include USP/NF, EP, JP, BP, FCC, JPE, ACS, AOAC, AOCS and ASTM. We are adding new tests to our arsenal daily. Currently, over a number of different tests have been performed at our facility. Alternative methods to compendial procedures are frequently required. They can be supplied by our clients, or their vendors. Many times, we develop new methods, and if needed, validate them. Whatever is used, we are there to help you decide what is appropriate.

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Pharmaceutical Assays

An assay is a procedure in molecular biology for testing or measuring the activity of a drug or biochemical in an organism or organic sample. A quantitative assay may also measure the amount of a substance in a sample. Bioassays and immunoassays are among the many varieties of specialized biochemical assays. Other assays measure processes such as enzyme activity, antigen capture, stem cell activity, and competitive protein binding.