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Choksi Laboratories Receives Enhanced CDSCO Approval for Medical Devices Quality Assessment We are thrilled to announce that Choksi Laboratories Limited (CLL) has received enhanced scope approval from the Central Drugs Standard Control Organization (CDSCO) for the testing and evaluation of medical devices. This expansion strengthens our commitment to ensuring high-quality and regulatory-compliant medical devices for the healthcare industry. Expanded Scope of Testing The approval now covers 59 medical devices across various classes, allowing CLL to conduct comprehensive chemical, microbiological, and elemental analysis. Some of the critical quality parameters included in our expanded scope are: Chemical Characterization – Identification of the chemical composition of medical devices. Extractables and Leachables Assessment – Evaluating potential chemical compounds that may migrate from the device to the patient. Sterilization Residues Testing – Detection of Ethylene Glycol (EG), Diethylene Glycol (DEG), Ethylene Oxide (EO), and Ethylene Chlorohydrin (ECH) to ensure product safety. Elemental Analysis – Determining the presence of extractable and total elements that could impact device performance and safety. CLL already had an approved scope for microbiological testing of medical devices. With this enhanced scope, we are now positioned to provide a comprehensive suite of quality assessment services for a broader range of medical devices.  Medical Devices Covered in the Expanded Scope Our state-of-the-art laboratory can now test and evaluate a diverse range of medical devices, including but not limited to: IV Bags and Sets Catheters Lenses & Contact Lenses Dental Implants and Orthopedic Implants Cardiovascular Devices and Stents Surgical & Non-Surgical Gloves Intrauterine Devices (IUDs) Nebulizers, Aspirators, and Inhalers Face Masks, Nasal Masks, and Oral Masks Commitment to Quality and Compliance At Choksi Laboratories, we uphold the highest standards of testing and regulatory compliance. Our advanced analytical capabilities, combined with our expertise in pharmaceutical and medical device testing, ensure that we deliver reliable, accurate, and regulatory-compliant results. With this CDSCO-approved enhanced scope, we reaffirm our commitment to supporting medical device manufacturers, importers, and healthcare providers in delivering safe and effective medical solutions to the market.🔬 For inquiries about our medical device testing services, contact us today!  

Nitrate, Nitrite and NDMA in Lactose Risk Assessment and Analytical Perspective What is Lactose? Lactose is a sugar (disaccharide) naturally present in milk. About 2-8% of milk content by weight is Lactose. Lactose contains one molecule of glucose and one molecule of galactose. Lactase, an enzyme in human gut, breaks down the Lactose in its constituents. Lactose Applications in Food and Pharmaceuticals Lactose is used mainly in infant milk powders, food additives and in pharmaceutical formulations as an excipient. Its physico-chemical properties such as compressibility and palatability make it an ideal excipient for pharmaceutical preparations. Several OTC drugs such as painkillers, anti-inflammatory drugs, antacids, birth-control pills, dry powder inhalation products etc. use Lactose as a diluent, excipient or carrier. How is Lactose manufactured? Commercially available lactose is manufactured by evaporation, crystallization, and refining from whey permeate separated after production of cheese & other milk products. Nitrate, Nitrites and Nitrosamines in Lactose Relationship of Nitrate, Nitrites and Nitrosamines Nitrate and Nitrite are naturally present in milk from various sources such as ingestion of nitrates and nitrites by dairy cows during grazing and drinking, nitric acid used during the sanitization of dairy equipment, etc. A 2008 study4 carried out on several market drugs, provided following Lactose contents: Group name Generic name Lactose per tablet (mg) Maximum no. tablets per day Theoretical total lactose ingested per day (mg) Antimuscarinics Dicycloverine hydrochloride 74 6 444 Propantheline bromide 38 8 304 Other antispasmodics Mebeverine hydrochoride 95 3 285 99 3 297 Anti-motility drugs Codeine phosphate 46 8 368 Loperamide hydrochloride 125 8 1000 108 8 864 Aminosalicylates Mesalazine 75 6 450 Corticosteroids Budesonide 600 3 1800 Prednisolone 31 12 372 Immunosuppressants Azathioprine 71 3.5 248.5 Mercaptopurine 61 2 122 Methotrexate 28.9 6 173.4 Nitrate and/or Nitrite react through various biological or chemical processes convert to NDMA3,4. Some of the processes in production of milk powder / lactose such as equipment disinfection, acidification, and heating in directly heated spray dryers, may cause production of NDMA in final product. One of the possible routes of NDMA formation from Nitrite ion NDMA is a known carcinogen and an analyte of concern. The ADI (Acceptable Daily Intake) established by US-FDA for NDMA is 96ng/day. Roughly, this translates to following limits in lactose assuming a 100mg/tablet lactose contribution: Excipient Theoretical Intake (Dose) per day QC Specification Limit – NDMA Lactose(100mg/tablet) One tablet daily dose 0.96ppm Two tablets daily dose 0.16ppm Four tablets daily dose 0.08ppm Given this, lactose has a major potential to contribute Nitrate, Nitrite or NDMA itself to the drug product. Nitrite, Nitrate Acceptable Daily Intake A study1 published by US-FDA researchers in Journal of Agricultural and Food Chemistry, in January 2020, reviewed Nitrate, Nitrites in animal as well as plant based milk and milk products. The study found that out of 71 commercial milk powder samples, 67 had Nitrate content > 1.5mg/kg (1.9mg/kg being the lowest and 395mg/kg being the highest). In addition, a smaller subset of these samples were also tested for NDMA content and found NDMA content in all tested samples Acceptable Daily Intakes for Nitrate and Nitrite as per WHO Nitrate ADI Nitrite ADI ADI (mg/Kg of body-weight) 3.7 0.07 Limits for an Adult, mg/Day (60kg body weight) 222 4.2 Analytical Method by Choksi Laboratories Ltd. Lactose is a challenging matrix as the sugar can lead to rapid column degradation. Therefore, it is extremely important to ensure that the column loading is managed to ensure that nitrate and nitrite are separate well while reducing matrix interference to minimum. We used a Dionex 5000plus Ion Chromatogram equipped with ASRS 300. IonPac®AS14A Analytical 4 × 250 mm column was used with analytical guard column of same packing. Nitrate, Nitrites and Nitrosamines in Lactose Standards and samples were matrix matched by using standard addition method, to further reduce interference. System Suitability: As can be seen in the chromatogram, both Nitrate and Nitrite were well resolved. There was no matrix interference. And a linear regression determined the coefficient of determination to be 0.9996 (well over the acceptance limit of 0.995). Results: Lactose samples typically showed nitrate concentrations at about 1.9ppm to 10ppm. Nitrite was not detected in any sample tested in the study. Further NDMA studies were carried out in GC-HS-MS/MS equipped with HES source, and utilized back-flushing technique to remove other contaminants from column. LOD/LOQ: Typical LOD, LOQ values established are given below: Nitrate, ppm Nitrite, ppm NDMA, ppm LOD* 0.005 0.005 0.001 LOQ* 0.01 0.01 0.003 (*): On instrument With this study at CLL-Indore, a rapid methodology was established to analyze Nitrate and Nitrite in Lactose samples, followed by NDMA estimation by GC-HS- MS/MS, meeting current regulatory requirements quite easily. Reference Documents: J. Agric. Food Chem. 2020, 68, 6, 1725– 1730, Publication Date: January 22, 2020 : Investigation into the Concentrations and Sources of Nitrates and Nitrites in Milk and Plant-based Powders, Susan Genualdi, Mayara P. V. Matos, John B. Mangrum, Lowri DeJager WHO/HSE/AMR/08.03/8: N- Nitrosodimethylamine in Drinking-water, Background document for development of WHO Guidelines for Drinking-water Quality, 2008 EPA Technical Fact Sheet – N-Nitroso- dimethylamine (NDMA), January 2014 Quantifying the ‘hidden’ lactose in drugs used for the treatment of gastrointestinal conditions, P. EADALA,J. P. WAUD,S. B. MATTHEWS,J. T. GREEN,A. K. CAMPBEL.

The U.S. Food and Drug Administration (FDA) has expanded its public health alert to include more ground cinnamon products due to the presence of elevated levels of lead. This action follows rigorous product testing conducted by state programs and confirmed by the FDA. Consumers are strongly advised to dispose of and refrain from purchasing these products. Key Points of the Alert: Elevated Lead Levels Detected: Recent testing has revealed that certain ground cinnamon products contain elevated levels of lead. These products pose a significant health risk, particularly with prolonged exposure, and should be discarded immediately. Voluntary Recalls: The FDA has recommended that companies voluntarily recall these products. The list of affected products continues to grow as more brands are identified. The FDA will update this alert with information from companies that agree to recall their products. Ongoing Investigation: The FDA, in collaboration with state partners, is continuing to analyze ground cinnamon samples. This public health alert will be updated as more data becomes available. As of now, no illnesses or adverse events related to these products have been reported. Background: This is the third public health alert issued by the FDA this year concerning ground cinnamon, reflecting the agency’s commitment to ensuring the safety of food products, especially those frequently consumed by children. The alert recommends recalls of nine brands of ground cinnamon, with lead levels ranging from 2.03 to 7.01 parts per million (ppm). These levels, while lower than those found in the WanaBana cinnamon apple puree and applesauce products recalled in 2023, still present a significant health risk. The FDA’s targeted assessment and subsequent alerts have been supported by data collected through the Laboratory Flexible Funding Model (LFFM), a cooperative agreement with state partners. States including California, Maryland, Missouri, Connecticut, and Virginia, along with the New York State Department of Agriculture and Markets, have contributed to the sampling efforts. Recommendations for Consumers: Check and Dispose: Consumers should immediately check their homes for ground cinnamon products and dispose of any items listed in the alert. These products have a long shelf life, so it’s important to verify any ground cinnamon you may have stored. Do Not Use or Purchase: Avoid using or purchasing ground cinnamon products identified in the alert. The FDA advises against consuming, selling, or serving these products due to the health risks associated with lead exposure. Seek Medical Advice: If there is any suspicion of lead exposure, particularly for vulnerable groups such as children and pregnant women, contact your healthcare provider for guidance. Although many people may not exhibit immediate symptoms of lead exposure, prolonged ingestion can lead to serious health complications. Report Adverse Events: If you or someone you know experiences adverse effects or illness after using these products, report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. You can submit reports online, by fax, or by mail. For more detailed information about this alert and the list of affected products, please visit the FDA’s official MedWatch page.