LLC Laboratory is a GMP testing laboratory in the heart of Mississauga, Ontario. LLC Lab possesses Health Canada Establishment License. We have state of the art laboratory instruments and our staff have extensive pharmaceutical experience.
LLC Lab offers fast and high quality contract testing service for all your testing needs. We test pharmaceutical, nutraceuticals, cosmetic and medical device products. Our vast range of services comes with comprehensive support from our professional and reliable staff.
We value each and every customer and treat all projects with utmost importance: no project is too small or too big. You can rely on personalized, one-on-one service, focusing on your objective. As part of our commitment to help you succeed, we maintain communication and encourage your involvement with every critical step of the project.
What makes LLC Laboratories different from other laboratories is that our staff have worked at pharmaceutical companies including brand-name, generics, CMO and CRO, and contract testing labs, and have been clients to several contract testing laboratories in the past. We understand the importance of receiving results on time, avoiding costly production delay. Every day counts. We also have experienced research scientists who can help with non-routine testing. You can be sure that we can provide results to meet your production schedules and research and development needs.
We also offer consultant services – sharing our vast knowledge and experience making it easier for you to achieve your requirements. We can provide quality assurance, quality control, method development and validation, problem solving, technical data review services, among others. Whether you need support during start-up, license application, audit preparation, or addressing inspection observations, we are here to help.
Our pricing is competitive and within industry standards. We also provide quantity discounts and rush/emergency services.
USP General Chapter <231>, <232>, <233> for pharmaceutical products and <2232> for dietary supplements and even Cosmetics require to test heavy metal and element impurity and elemental contaminants. Trace metals analysis service to support clients involved in drug development and manufacturing of pharmaceuticals, biopharmaceuticals, chemicals, biocides, contamination testing and others.
We have Agilent 7700 ICP-MS which can accurately and precisely determine elemental impurities.
Trace metals testing is a routine activity in our cGMP analytical laboratory. Pharmacopeia methods <231>, <233> and <2232> or clients specific methods services are available. LLC Laboratories can provide inductively Couples Plasma (ICP) with Mass Spectrometry detection metals analysis services including heavy metals testing and elemental analysis. In addition, LLC Laboratories offers elemental analysis for other industries as well.
LLC Laboratories can provide various range of stability conditions, including the most commonly used: 5±3°C, 25°C/60% RH, 30°C/65%RH, and 40°C/75%RH. We can develop stability programs, conduct the stability study as well as forced degradation tests at any stage of the product development in compliance with ICH, US-FDA, and Health Canada regulatory requirements.
We can offer the following services for the stability study:
Stability Protocol Design and execution
Forced degradation studies protocol design and execution
Development and validation of “stability indicating methods”
Long term stability
Customized condition stability
Formulation evaluation stability
Stability testing for R&D stages of IND, NDA and ANDA
Commercial/post market stability
Forced degradation studies
Shipping Stability study including actual shipping, freeze/thaw study, cycle test, etc.
Stability trends to compare different packaging materials and container closure systems
Customized data recording and reporting, including OOT trending, available upon request
Stability Summary Report to present to CMC section or regulatory to support the product expiry date.
The use of in vitro release testing as a QA tool to ensure batch-to batch uniformity has been gaining both increasing popularity and contempt in the pharmaceutical industry. US-FDA has published a SUPAC guidance for the topical and transdermal drug products - In Vitro Release Testing (IVRT) and In Vivo Bioequivalence Documentation. Currently, the most publicized methods use horizontal (Franz) diffusion cells to conduct in vitro release studies on topical and semisolid formulations, typically creams or ointments. LLC Laboratories possesses in-depth knowledge in utilizing Franz Cell for topical semisolid formulations and routinely works with synthetic, bio-materials and tissue membranes, including human and animal skin.
The identity, purity and quality of raw materials used to produce any product needs to be ascertained with industry-approved test procedures. We can test every raw material to verify if its specifications is met before it is deemed acceptable for use. With such a wide variety of raw materials available, a vast range of tests and testing instrumentation are required. Common testing includes: Identification of the raw materials including ID test for each container, determination of loss on drying, moisture content, heavy metals, limit tests, and bulk density. Assays can be performed using UV-Vis spectrophotometry, Titration methods, and HPLC or GC analysis, etc.
LLC Laboratories’ analysts have extensive industry experiences testing raw materials including solid, liquid and semi-solid forms. We understand the demands to analyze raw materials to meet your production schedule. Our turn-around times are second to none.
As part of our service, provide support in qualifying new vendors and new raw materials in these industries:
Whether it is compendial methods or supplier provided methods trust LLC Laboratories to provide you with accurate, fast and reproducible results. We perform method verification of compendial methods, method transfer or inter-laboratory qualification of your supplier’s methods to establish suitability under actual conditions of use.
Assay and Impurities by HPLC
Assay and Identification by UV-Vis Spectrophotometry
ID by FTIR
Moisture Content by Karl Fischer
Loss on Drying
Assay by titration
Compendial Tests listed in USP General Chapters and EP Methods
General analytical laboratory services.
LLC Laboratories has the expertise in analysis residual solvents and organic volatile impurities using USP <467> and ICH Q3C methods for the following Residual Solvents Determination of Class 1, Class 2, Class 3 and other solvents. We also can develop a specific methods for the specific solvents to individual raw material.
Class 1 solvents in pharmaceutical products (solvents that should be avoided)
Class 2 solvents in pharmaceutical products
Class 3 solvents which should be limited by GMP or other quality based requirements
Other Residual Solvents (For which no adequate toxicological data was found)
Methyl isopropyl ketone
For specific raw materials used in pharmaceutical products, US-FDA has established a guidance to test the Melamine content. Melamine is a widely-used intermediate, mainly employed as a raw material for producing melamine resin and is a chemical most often found in plastic materials. Long-term or mass intake of melamine has toxic effects and may lead to reproductive damage or bladder or kidney stones, which can also lead to bladder cancer.
LLC Laboratories can provide melamine testing to pharmaceutical raw materials, the dairy and dairy-related industries and also to food retailers. We offer a method for the analysis of melamine:
Using GC-MS (according to the official FDA method) melamine and its homologues cyanuric acid, ammeline and ammelide can be detected in the ppm range. Detection Limit (DL) for melamine: 2 mg/kg (ppm).
LLC Laboratories offers a full spectrum of methods including UV, HPLC, GC, ICP-MS, FTIR and In-Vitro Release for topical. We perform analytical method development in accordance with client’s requirements, US-FDA and Health Canada, USP and ICH guidelines and ensure you meet all regulatory requirements.
Analytical method development services include assay, impurities, identification, and limit tests for the following materials or purposes:
Active Pharmaceutical Ingredients (APIs)
Drug product development
Cleaning agents used in manufacturing processes
Forced degradation studies
Process impurity method development
Cleaning validation method development
Stability indicating methods
LLC Laboratories has very experienced validation professionals in method validation specific to your needs. Our method validation practices follow Health Canada, ICH, USP and US-FDA methods validation characteristics requirements for various types of tests. The typical validation characteristics such as Specificity, Linearity, Range, Accuracy, Precision, Quantitation limit, Detection limit, Robustness and/or Ruggedness are included pending on the nature of the analytical methods. In addition, method validation also includes filter study stability of analytical solutions and system suitability.
For in-vitro analytical methods, LLC Laboratories can perform the method validation using Franz Cell for topical and transdermal drug products. The method validation will follow the FDA Guidance for Nonsterile Semisolid Dosage Forms, SUPAC guidance for IVRT or customized parameters for client’s specific products.
Method validation services can provide for the following studies:
Quantitative tests for impurities’ content;
Quantitative and Limit tests for the control of impurities;
Quantitative tests of the active moiety in samples of drug substance or drug product or other selected components in the drug product
Stability indicating assays
Forced degradation studies
LLC Laboratories has been providing quality consulting services to the manufacturers of health care products. In highly regulated industries, there is a need for experienced specialists who can provide solutions in a cost effective and timely manner.
LLC Laboratories provides consulting services that specializes in quality assurance management and documentation, audit and inspection management, risk and crisis management, quality control management, instrument qualification/validation, analytical method development and validation, troubleshooting and problem solving, technical review services, quality gap analyses, regulatory affairs, and training. We provide a wide range of services to the pharmaceutical, biotechnology, medical device and nutraceutical industry. We are here to assist your company with any issue you may be facing.
All pharmaceutical clients focus on the testing efficiencies to increase the testing productivity and reducing the cost. LLC Laboratories has vast experience and proof records in managing the lab to change the lab culture and the scheduling to dramatically increase the testing efficiencies, while the lab maintains the enthusiasm and moral.
At LLC Laboratories, we have a highly qualified and dedicated professional team who believes quality plays an integral role in every facet of our activities. Our presence ensures we are current with regulatory practices and ahead of the emerging trends regarding QA, QC, Validation, RA and training. Our staff brings a variety of disciplines to the table, to ensure every aspect of your project needs are met. LLC laboratories is a multicultural company with staff servicing companies of all sizes. We are confident that we are the solution you need to operate in this highly regulated industry.
"I am very satisfied with their work."
LLC Laboratories Inc has not received any endorsements.