Pharmaceutical, cosmetic and chemical industries have opened up markets in recent years resulting in widespread availability of healthcare products. In such a competitive and sensitive market, product quality and safety, and adherence to industry norms and standards act as the key differentiator for pharma and healthcare industry.
This is where the importance of pharmaceutical testing and analysis comes into play. It helps to regulate, curb and maintain the quality and safety of drugs, cosmetics and chemicals. Pharmaceutical testing and analysis also plays a pivotal role in the development process and GMP manufacturing.
Pharmaceutical testing helps to determine the quality and quantity of the pharmaceutical products. It provides information about the purity and safety of the products thus making it possible for and food and drug companies to obtain desired certifications for adherence to industry standards.
At Precise Analytics Lab., we have state-of-the-art infrastructure, modern diagnostic resources and the niche expertise to conduct the end-to-end quality control testing process. Versatile and highly sensitive analytical methods based on analytical instrumentation are employed in our pharmaceutical testing laboratories to isolate samples, determine and identify their compositions, and quantify drug substance and its impurities.
We adopt physical and chemical testing for the chemical, pharmaceutical, and cosmetics industry to validate various parameters and ensure adherence to globally recognised standards and protocols. In addition to testing the active ingredients present in samples, we also conduct tests to determine other properties exhibited by the pharmaceutical or cosmetic product.
We have exclusive analysis laboratories and pharmaceutical testing laboratories for each section, which ensure high standards of quality and precision. Individual pharmaceutical testing parameters are allocated for samples based on latest regulatory norms and are continuously updated to facilitate industry certifications and meet quality standards. Such stringent and industry-approved measures along with the knowledge of our team of in-house experts ensure we provide uncompromised and timely analytical testing services, every time.
Below is a glimpse of the sample categories we analyse and the corresponding parameters we evaluate.
To learn more about our pharmaceutical testing services, click here.
At Precise Analytics Lab., we offer testing services for a wide spectrum of samples – solids, liquids and gases; raw materials, products under development, and finished products; food, chemicals and drugs; and more.
Due to the varying nature of samples and the diverse parameters involved, testing requires analytical equipment designed for complex, end-to-end quantification. Equipment should be highly sensitive to detect trace contaminants even with minimal sample available. Additionally, instruments should be able to provide accurate test results for samples obtained at different stages of product development.
Precise Analytics Lab. is equipped with the latest analytical instruments such as:
The GC lab. at Precise Analytics offers micro-level testing of samples with its updated gas chromatography detectors. Our GC lab. is also equipped to perform the latest headspace GC sampling technique to determine volatile components using the headspace in the chromatographic column.
The following are some of the testing services available at our GC lab.:
One of the most insightful analytical separation techniques employed worldwide, HPLC analysis is used for separation of individual components from a complex mixture through a mobile phase. Some of the offerings at our HPLC lab. include:
Accuracy and sensitivity are an integral part of the industry we operate in, and a micro discrepancy can lead to macro impact. With this in mind, we offer the latest FTIR analysis technique that has wide-spectrum applicability for identification of chemical bonds.
Precise Analytics Lab. boasts of FTIR spectrometer from Shimadzu equipped with DRS (Diffuse Reflectance Attachment) for liquid samples and ATR (Attenuated Total Reflectance) for solid samples. Adoption of these FTIR analysis technology guarantee high resolution and sensitivity that facilitate accurate results.
We perform the following FTIR analysis tests:
Our analytical testing services may involve the use of a single technology or instrument, or a combination of these based on the nature and type of sample.
Therefore, Precise Analytics Lab. has a range of other instruments, which cater to current industry needs and facilitate routine laboratory analyses, such as dissolution testing. Inevitable for the pharmaceutical industry, dissolution testing gauges the bioavailability and therapeutic effectiveness of a drug by measuring the rate of dissolution of a capsule, tablet, etc. Our high-technology dissolution apparatus provides accurate and reproducible results consistently.
The following are the various instruments that enable precise and timely results:
Learn more about the facilities of our GC lab., FTIR analysis services, dissolution testing services, and other offerings and make the precise choice.
Vital in the pharmaceutical industry, analytical method development and validation ensures relevant, reliable and reproducible results. At Precise Analytics Lab., we offer regulatory-focused, phase-appropriate and sample-specific technology for pharmaceutical validation and method development.
Our development and validation methods for pharmaceutical industry conform to the regulatory requirements prescribed in relevant ICH, USP and other pharmacopeia guidelines. We also emphasise on maintaining client-specific protocols in our analytical method development and validation processes. Sophisticated analytical technology, latest know-how of chemicals and drugs, and thorough understanding of current regulatory practices guarantee sensitive, accurate, specific and precise results.
We undertake analytical method development and validations for chemical and pharmaceutical analytical procedures.
The samples are tested against the following validation parameters:
We undertake Analytical Method Development comprising process validation and cleaning validation for pharmaceutical products and bulk drugs.
Process validation is a documented series of actions that prove that any equipment, process, procedure, material, activity, or system performs its intended functions adequately and consistently, and lead to the predetermined results of uniform batches that meet the required specifications and quality attributes.
Process validation is carried out by using a document plan stating how validation will be conducted, including test parameters, product characteristics, and production equipment and decision points on what constitutes acceptable results.
In the pharmaceutical industry, process validation plays an essential role in the validation cycle. Based on initial formulation development of the drug, critical parameters are identified, which are then optimised and validated.
Validation tests are conducted at each stage during the process and results compared with the benchmarked acceptance criteria. Replication studies are conducted on a minimum of three consecutive batches to ensure validation, precision and repeatability critical in the pharmaceutical industry.
At Precise Analytics Lab., we assess existing validation methods for pharmaceutical industry, identify gaps if any and deploy suitable improvement techniques for validation success.
Cleaning validation is a technique employed to verify that processes and procedures used to clean the product residue from process equipment and components will consistently and significantly reduce the amount of active ingredients/excipients and cleaning agent to a concentration within calculated acceptance limit.
For the pharmaceutical industry, microbial contamination, residue levels, active ingredient levels, etc. form the core that can determine the success or failure of a drug validation. Therefore, cleaning validation is conducted in accordance with a documented plan stating how cleaning will be conducted, sampling plan, including test parameters, product characteristics, and acceptance limit.
Chemical determination of the previous product is done at ppm levels. Detergent residues are also analysed in ppm level. Additionally, microbial contamination is checked for optimised validation.
Precise Analytics Lab. is geared up to be your partner in validation in the pharmaceutical industry. Explore our world-class analytical method development and validation for high-level precision.
In recent years, the food industry has been under scrutiny at various levels – from farm ingredients to the finished food sample – for their quality, nutrition levels, potential toxicity, and potential contamination, among others. Increasing incidents of adulteration and discovery of spurious items that are harmful to health have reinvented the food testing industry to meet higher standards across the food cycle.
This scenario underlines the food safety aspect for both the manufacturer and the end consumer. Based on the sample and client needs, individual analysis may be required for quality, toxicity, presence of heavy metals, presence of microorganisms and extraneous matter, etc. Alternatively, a sample may also demand a test solely for its nutritional value.
Additionally, with the swell in can and packet food, shelf life testing of food and agricultural products has become a key testing parameter. Shelf life of food is determined by multiple microbiological, physical, chemical and environmental factors that act on food at various stages of its life. This makes shelf life testing complex and unique for each sample.
Accurate determination of shelf life through shelf life testing is critical for food manufacturers to provide good quality and safe products to their consumers. For an industry that is highly sensitive in nature, shelf life testing reduces the risk of product spoilage and product recall. For the manufacturer, precise understanding of the shelf life increases repeat buys and profitability.
Our state-of-the-art laboratories employ high quality shelf life testing processes that conform to accredited quality standards. We customise our shelf life testing analyses to suit the needs of the manufacturer and the sample involved. Thus, our shelf life tests help you determine accurate dates that conform to statutory safety requirements for your products.
We also carry out nutritional analysis of different food varieties, which is relevant for industrial compliance and for nutrition label generators. Our latest analytical techniques determine intrinsic measures such as calories, carbohydrate, protein, fat, vitamins minerals, and fibre content present in the given sample. In addition to providing the nutritional value details, nutritional analysis also generates vital information to be declared on nutrition labels.
Precise Analytics Lab. provides accurate inputs through thorough analysis and generates relevant information to help you meet the desired regulatory requirements. Our norm-based assessment and report generation avoids certification delays for products to reach the shelf. We offer sound guidance at every step based on relevant industrial norm changes to ensure your quality-checked product reaches the target market in minimum turnaround time.
Reach out to us to know more about how we can help in shelf life testing, nutrition label testing, and more.
Microbiology is an important area of research for the pharmaceutical industry. Microbiology becomes vital due to widespread involvement of microbes in various diseases. Subsequently, development of vaccines to diagnostic medical devices is directly or indirectly determined by microbiological studies.
Drug quality, safety and efficacy are the most important aspects of microbiological testing of pharmaceutical products. The presence of any pathogenic bacteria, yeasts, moulds or bacterial toxins produced by microorganisms is strictly regulated microbiology testing laboratories to ensure minimal or zero risk.
At the microbiology testing laboratories at Precise Analytics Lab., we conduct antimicrobial effectiveness testing of pharmaceutical products strictly as per pharmacopeia guidelines and using high-technology resources. Our microbiological testing lab is well equipped with Clean Room Partition, Air Handling Unit, Laminar Air Flow, Biosafety Cabinet, Deep Freezer, and more, to perform wide range of microbiological testing.
Tests carried out in our microbiology testing lab include:
In a world filled with microbes, species varying from beneficial to harmful to lethal for humans, there are ample opportunities for food products to be contaminated “from farm to fork”.
To ensure safety of food products, microbiological tests such as testing for pathogens and spoilage organisms are required. Through this, the risk of contamination under normal use conditions can be examined and food poisoning outbreaks can be prevented. Testing of food products and ingredients is important along the whole supply chain as possible flaws of products can occur at every stage of production.
Our well equipped microbiology testing lab and well qualified, experienced microbiologists ensure accuracy and reliability of results.
We carry out following microbiological tests in food products and ingredients across standard parameters recognised worldwide:
Contact us and learn the best Microbiological Testing available for your sample at our microbiology testing lab.
Earth is the ‘blue planet’ because water covers almost 71% of its surface. A universal beverage and a liquid essential for sustenance, water is found almost everywhere on our planet in varying forms. The availability of water from different sources and its significance in the ecosystem make water testing crucial at an industrial and individual level.
Based on the water sample source as well as individual client needs – determined by end usage – the type of water testing or analysis required differs. Water analysis helps to ascertain the composition and purity of water, thereby classifying it as suitable or unsuitable for use. Water analysis or testing involves measuring the quality of water based on physical, chemical and microbiological characteristics. Further, water testing needs to be done at regular intervals since the nature and composition of water can change over time.
Water analysis ranges from simple water testing processes, where a single component is analysed, to complex processes for multi-component analysis. Additionally, mineral water testing to determine whether it is potable involves separate analytical techniques as opposed to water for industrial use. Apart from input water sources, waste water from industries also undergoes analysis. Water testing of industrial waste water is often carried out to check for the presence of hazardous chemicals or harmful radiation traces and check further pollution or damage to any water or land bodies to where they may be flushed out as effluents.
Water contamination and pollution is one of the leading causes of disease and death globally. According to a study in The Lancet, water pollution caused over 10 lakh deaths in 2015. About 100 crore of the global population fall ill annually due to unsafe water.
Damage to water bodies not only adversely affects the human population but is also detrimental for other ecological populations that lend balance to our sensitive ecosystem. Thus, water testing becomes critical from a health as well as ecological perspective.
Taking these multiple factors into consideration, Precise Analytics offers multiple tests for water samples using our well-equipped water testing labs and scientific expertise. Water testing is conducted to check:
The water analysis includes chemical as well as microbiological testing as per IS, IP, BP, USP, EP and other globally recognised standards. We also offer mineral water testing services at our water testing labs.
Below are some of the sample categories of water we test in our water testing labs:
Learn more about our water and mineral water testing services in Mumbai.
Trace metal analysis is an analytical technique employed to determine the presence of trace metals and quantify them in chemical and pharmaceutical samples, drug formulations and food samples. Trace metal analysis plays a significant role in the formulation and development of drugs, chemicals, cosmetics, medical devices, etc. by determining, identifying and quantifying the trace metals in a sample.
While they are present only in scant levels, trace metals can still act as potential deterrents in drug efficacy, for example. Thus, to prevent product risks, and understand the nature and quantity of trace metals, analysis is essential. Additionally, determination of trace metals or chemical testing can result in process improvement and enhanced product quality and efficacy.
Most importantly, any harmful side effects from these trace metals can be identified, which is especially critical in oral and topical use of food products or formulations. The interaction of the trace metals with other metals or chemicals in the compound could act in reverse or result in dangerous effects. Trace metal analysis or testing makes manufacturers aware of the potential danger and protect end users.
We conduct trace metal analysis in our technologically upgraded metal testing labs for superior results. Trace metal analysis is performed using ICP-MS of Agilent Technology with latest Mass Hunter software. Elemental impurities are analysed as per USP and ICH Q3D. Since the presence of these metals are at trace levels sensitivity of the technology and equipment utilised is key for high accuracy results.
Our team of experts stay abreast of current global regulatory standards for permissible limits of trace metals, which are frequently changing. Their analytical and legal knowledge coupled with latest, versatile technology in our metal testing labs lend us the upper hand in providing our clients accurate results.
Based on client needs chemical and metal testing is done to ppm, ppb, and ppt levels, to ensure accuracy and reliability. Our chemical testing labs are equipped to test for the presence of the following metals/chemicals:
We also undertake method development and validation projects by ICP-MS.
We have AAS of Perkin Elmer with Flame and MHS technique. Following are the tests performed on AAS for chemical and metal testing in our metal testing labs:
Learn more about our trace metal testing and chemical testing services.
Stability testing of pharmaceutical products and storage follow a complex set of procedures involving considerable time, cost and scientific expertise in order to build in quality, efficacy and safety in drug formulations. Stability testing or GMP stability testing is critical at every step during drug or product development to determine the shelf life and storage conditions in conformance with stipulated standards.
Stability testing or studies is some of the most important step during the drug development process because it is required to assure the identity, potency and purity of ingredients, as well as those of the formulated pharmaceutical products or Active Pharmaceutical Ingredients (API). Evaluation of these formulations or products against varying environmental conditions such light, temperature, moisture, etc. provide relevant, real-time insights about their applications and how they may differ due to changes in storage factors.
For a pharmaceutical or chemical company, choosing an experienced stability partner who possesses the right infrastructure – such as stability walk-in chambers, photostability chamber, etc. – and the analytical resources for stability testing can determine the product success or failure.
Precise Analytics Lab. is well equipped with stability walk-in chambers that can be set at different temperatures and humidity with validated monitoring systems. We also have a photo stability chamber to carry out photo stability testing. Our technologically-enhanced stability testing labs and experienced analysts and scientists provide GMP stability testing for pharmaceutical companies.
We carry out all ICH and Specific Conditions stability studies and the stability studies are carried out under the following range of stability conditions.
| Temperature | Humidity |
|---|---|
| 30°C ± 2°C | 65% ± 5% |
| 30°C ± 2°C | 75% ± 5% |
| 40°C ± 2°C | 75% ± 5% |
| 25°C ± 2°C | 60% ± 5% |
| 2°C - 8°C | No Humidity |
The features offered by our stability testing labs include:
Our stability testing processes serve to enhance product and drug development by critical identification of stability that is essential for product validation. Stability testing involves determining degradation factors and time taken for degradation. Routine assays for various parameters such as temperature, moisture content, residue presence, microbial presence, etc. are also conducted.
During the period of stability testing, we periodically test for identification, physical appearance, disintegration, dissolution, loss on drying, related substances, assay, residual solvents, microbial testing etc., to determine the accurate stability of product. Our experienced team and high-technology infrastructure complement each other to provide stability studies that are reliable in real-time conditions thought the product lifecycle.
Forced degradation studies during stability testing include the following parameters:
Contact us for your stability testing or photo stability testing needs.
Production of Pharmaceutical, Nutraceutical , Cosmetics and healthcare formulations including Capsules, Tablets, Liquid orals, topical preparations at our multisite international operations.
Precise Analytics Lab. was established to provide an unmet need for high quality specialized analytical services, with rapid turnaround.
The facility was chosen by its prime location of the Thane city and began Chemical, Instrumental & Microbiological testing in October 2009.
"Precise Analytics Lab. We are committed to total customer satisfaction in Chemical, Microbial & Instrumentation Testing services, to the Pharma, Chemical, Food and drug industry."
Following good quality, ethical and professional business practices
Following adequate National / International laboratory standards of services
Following requirements of IS/ISO/IEC 17025 Standard
Continual improvement in effectiveness of the management system
Development of Human resources
Performing test & Providing Test results on Time and at competitive price
BIS Approved, Government and FDA Approved Lab
We are absolutely delighted with the quality of work we have received from Precise Analytics Lab, and the time saving we have made. We interacted with different peoples in the different projects and were every time Precise Analytics Lab. completed the projects in time. We learned from Precise its exceptional client centric approach. We highly recommend every individual Precise Analytics Lab. We wish all great success and look forward to work again with Precise Analytics Lab.
Precise Analytics Lab has well equipped facilities, technically strong, hardworking and supportive staff. They do the best for fulfillment of customer requirements. Their accurate and precise results in stipulated time limit prove their competency. Our best wishes are always there with them.
Precise Analytics Lab is equipped with advanced techniques, sophisticated instruments and all facilities to serve best quality, precise and accurate results in short time frame. Laboratory staff is technically competent, hardworking and co-operative. They are taking lots of efforts for developing methods as suitable for products. We wish the all the best for their future endeavors.
Sincere, honest and good people to work with. Always putting the work on priority. Our year long association with Precise Analytics Lab. has keep upgrading our relationship stronger and stronger. A private lab equipped with all the techniques, facilities and upgraded equipments for serving a best in a class with respect to quality and precise results. Wishes them all the best and keep the good quality work enforced as always. Best of luck for your endeavouring future.
We take this opportunity to express all my gratitude & honest thanks to Precise Analytics Lab. for the timely supports to provide a testing reports to release the under test consignments for our mfg. process. In fact, Precise Analytics Lab. personnel’s are very co-operative, sincere & technically competitive to provide accurate results & achieving highest level of customer satisfactions through maintaining quality work at all times. Thanks for your supports as always.
Precise Analytics Lab. is an organization with a clear goal of providing the latest analytical services with fastest possible turnaround time. They never compromise on quality and follow regulatory guidelines religiously. As per my experience and interactions with Precise Analytics Lab. representatives, they can be ranked among the few topmost analytical service providers to chemical and pharmaceutical companies in region.
