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Validation & finished product release testing

Your partner for high-quality analytical testing

Fast and reliable analytical release testing is essential to any manufacturing process. ALS has been a trusted partner for release of OTC and prescription drugs for over 30 years. We have extensive experience with all OTC sunscreen, acne, and pain actives. ALS can validate client’s products using our in-house, tried-and-true methods or accept transfers of client methods. Most routine testing is turned around in 10 business days and rush can be available upon request.

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Committed to quality

As an independent testing facility, our internal quality effects all of our clients we serve. It is therefore built into ALS culture that quality and constant improvement are essential to properly servicing clients and sustaining their business. As a show of our commitment to quality and improvement, ALS ISO 9001:2015 certified, FDA registered (with and excellent inspection history), and some areas hold ISO 17025 for relevant tests as well. ALS strives every day to prove that there is no lab with higher quality standards.

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OTC Active Assay Validation 

ALS has a strong background in method development and validation for OTC Assays by HPLC, GC, or ICP. ALS can validate our in-house methods for client products or accept transfers of client methods. Our dedicated validation makes sure that validations and transfers occur quickly, so that stability and product release can be up and running as fast as possible.

ISO and USP compliant method validation

ALS clients can be assured that validations conform to USP and ISO expectations including appropriate parameters of: Accuracy, Recovery, Precision, Specificity, Linearity, Range, Limit of Detection, Limit of Quantitation, and Robustness.

OTC Active Ingredient Assays

Sunscreen and Acne product release testing are routine services of ALS. We are setup for high throughput of all common OTC actives (e.g. chemical sun filters, Titanium dioxide, zinc oxide, salicylic acid), so whether you have 5 samples or 50 samples, ALS is ready.

Method transfer and validation

When setting up for release or stability, clients have the option of performing method validation with our in-house methods or transferring in their own method. ALS accepts hundreds of client method transfers every year and knows how to make the process fast and simple.

Physical Tests

ALS regularly performs all standard physical tests such as color, odor, appearance, pH, viscosity, weight loss, and specific gravity. These can be performed for standard release if ALS is acting as a company’s central lab or as part of a stability study.

Vitamins and Supplement Testing

ALS has standard methods for testing of many common vitamins in either topical or oral forms. Common analysis include: Vitamins A, D, E, K, B (1-12), and C.

 Prop 65 testing

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Avoid prop 65 issues

ALS offers testing for all major Prop 65 chemicals in cosmetic and OTC products.

LEARN MORE about Avoid prop 65 issues