Stability Testing Services
Covalent can offer product stability testing in partnership with Green Scientific Labs for our customers who need it for retailer or regulatory requirements in their state for all products that are marketed as OTC drug products. (If your label has a "Drug Facts" panel, you need it.)
What is stability testing?
A stability study is a program of testing that is designed to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity light, which enables recommended storage conditions, retest periods and shelf lives to be established. (Refer to FDA Guidance for Industry Q1A(R2) “Stability Testing of New Drug Substances and Products".
All over the counter (OTC) and prescription (Rx) drug products distributed within the USA are required to display an expiration date that is supported by stability studies that have been conducted in accordance with the current FDA and ICH Guidelines. Each strength of a drug product, and each primary package and closure system in which it is distributed must be supported by stability testing. This requirement may be found in the Code of Federal Regulations, 21 CFR Part 211.137 – “Expiration Dating” and Part 211.166 – “Stability Testing”. If you are contracting this work to a third-party laboratory, be sure that they can provide guidance to help navigate the regulatory and compendial guidelines, and you perform a quality system audit of their facility.
The purpose of stability testing is to verify that no unexpected changes (organoleptic, claimed active ingredient potency(ies), contamination, etc.) take place during the period of the proposed shelf life for the product at the proposed storage conditions for such product. This verified testing (or combination of testing using accelerated conditions to extrapolate product shelf life) allows the manufacturer to predict a suitable shelf life for the product to meet consumer expectations. The stability of dietary supplements may be affected by environmental factors (i.e. temperature, moisture, oxygen), pH level, oxidization, water activity, and metallic ions. Not only is safety of utmost importance at the time of release in the manufacturing of cannabis derived products, but responsible manufacturers strive to assure their product’s safety, accuracy, and quality throughout out the shelf-life of its products.
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Available Types of Stability Studies
Stability testing is required to be conducted for OTC drug products under the recommended conditions of storage appearing on the label, and at any other condition, the drug product might be exposed to during manufacturing, storage and shipping activities. As a result, there are a number of stability conditions that are commonly utilized in determining the stability of a drug product in its marketed package(s). Examples of the most common stability conditions are as follows:
Real Time or Room Temperature (RT) Stability Study
A stability study conducted under controlled temperature and humidity approximating conditions of long-term storage. For drug products distributed within the USA, long-term stability storage conditions are 25 +/- 2oC with 60 +/- 5% RH.
Accelerated Stability Study
A stability study conducted under exaggerated conditions, in an attempt to accelerate the aging process, i.e., the rate of chemical degradation and/or physical change. For drug products sold within the USA, the most commonly used accelerated stability storage conditions are 40 +/- 2o C with 75 +/- 5% RH.
Intermediate Stability Study
A stability study that is conducted under conditions that are intermediate (between) long-term and accelerated storage conditions. For drug products sold within the USA, conditions are 30 +/-2oC with 65 +/- 5% RH. Samples stored under Intermediate conditions are typically only tested if a failure is encountered during the testing of samples stored under accelerated storage conditions.
Freeze / Thaw Stability Study
A study that is conducted at 5oC (no humidity control) to determine the effect that freezing and subsequent thawing has upon the stability of a product. Such studies may be conducted with single or multiple freeze/thaw cycles, with three cycles being the most commonly used.
A study that is conducted to determine the effect that either whole or ultraviolet light has upon the stability of a product. This is not required for drug products packaged in completely opaque container systems. (Refer to ICH Guideline Q1B “Stability Testing: Photostability Testing of New Drug Substances and Products”.)
Bulk Hold Stability Study
A stability study that is conducted under long-term conditions to assess the stability of a product batch in its bulk container. This applies to situations where a drug product may be stored in a bulk container for a period of time prior to its placement into end-user packaging.
Period After Opening (PAO) Stability Study
A study that is conducted to assess the stability of a product after its container system has been opened and then reclosed (but not ‘resealed’). This was first introduced within the EU but is now beginning to find acceptance within the USA.