Formulation stability testing why is it important?

Many brand owner get OEM sampling, look at the appearance, smell, look on the face, and feel good, and click mass production.

As a result, three months after the batch was in the bank, the product began to be layered; six months later, the color changed to yellow and the odor to acid; when the consumer received the product, the quality was completely different from that of the original test — the return, poor evaluation, brand crisis.

Often, there is only one root cause: unsystematic stability testing, or insufficient test cycles.

Stability testing is not optional and is a mandatory condition for the OEM process. It's a "pressure test" before the product is really mass production to help you anticipate any changes that might occur during the next 12-24 months.

I. Core logic of stability testing

Formulation is a complex chemical system in which ingredient reacts with time, temperature, light, packaging materials exposure. The essence of stability testing is to anticipate these changes in advance by accelerating modelling and real-time observation.

By analogy, it is like running a new car 100,000 kilometres under extreme conditions, which is tantamount to predicting whether it will go wrong after three years of normal use.

Stability is a common manifestation of failure

Stability testing

Type 1: Accelerating stability testing (Accelerated Stability Test)

Practising: Simulation of long-term aging by increasing the temperature, using 45°C/4 weeks to calculate the temperature for 24 months stability.

Note: Accelerator tests are extrapolations and are not a complete substitute for real-time tests. For some active ingredient (e.g. VC) degradation pathways at high temperatures are different from those at constant temperatures and the acceleration results may be optimistic.

Type 2: real time stability testing (real-time Stability Test)

Rationale: Follow observations on a real-time basis under conditions of constant temperature (25°C ±2°C, 60% RH) or near market storage.

That's stability's real silver. Usually requires:

  • At least 6 months real-time data completed before listing
  • At least 18 months of continuous follow-up during a fixed shelf period (e.g., 24 months)

Type 3: Cycle stability testing (Freeze-Thaw Cycling Test)

Rationale: Temperature changes experienced by simulated products in storage transport (e.g. winter freeze, summer heat shifts).

Standard programme: 15 °C (24h) ↔ 45 °C (24h) for a total of six cycles, each followed by detection of appearance, viscosity, pH.

Especially suitable for: lotion, frosts, fine with valid ingredient, and products from the tropical/cold zone market.

Brand owner to watch CHecklist

Physical appearance tests

  • [ ] Appearance (colour, transparency, evenness)
  • [ ] Smell (with or without variations)
  • [ ] Massive (intensity, ointment)
  • [ ] pH (no greater than ±0.5 for qualifying reference)
  • [ ] viscosity (rotational viscoscopy, change < 20% reference)

Chemical testing

  • [ ] Active ingredient content (HPLC determination of critical ingredient actual content)
  • [ ] VC class ingredient: Start content vs 6 months later
  • [ ] retinol content stability (specially sensitive)
  • [ ] Preservatives are valid concentration

Microbiological testing

  • [ ] Total aerobics (TAMC)
  • [ ] Total fungus and yeast (TYMC)
  • [ ] Preservative efficacy test (Challenge Test): artificial inoculation of microorganisms, observation of sterilization capabilities of preservative system
Preservative efficacy tests are one of the most important and easily omitted tests at present. National criteria refer to GB/T 27594-2011, EU market refer to ISO 11930.

Packaging materials compatibility test

  • [ ] packaging materials transport volume (polymerization of plastics, etc.)
  • [ ] packaging materials adsorption (activated ingredient adsorbed by packaging materials resulting in a decrease in concentration)
  • [ ] Sealability tests (preventing external contamination)
  • [ ] Functional test (pump head output stable)

Implementation node: schedule of stability testing in OEM process

Other Organiser

This article is published by the QuickOEM Make-up OEM Smart Matching Platform. More makeup OEM knowledge, cosmetics contract manufacturing, skin protection private label, make-up customizationontent are available at the Knowledge Centre. If you need advice on OEM contract manufacturing, please contact 1814805760 or submit your request through an online request for quotation.

Keywords: Precious, lotion, packaging materials, make-up shelf term, OEM, HA, emulsification, skin-care quality control, emulsification body, OEM formulation stability, CHA, formulation test method, VC, retinol, cosmetics stability testing, make-up OEM knowledge, cosmetics regulatory filing guidelines, regulatory compliance (EU / US FDA), ingredient compliance, formulation R&D

QuickOEM is a QuickOEM platform for vertical digitization of cosmetics services (known as QuickOEM) focusing on OEM, cosmetics contract manufacturing, skins private label, cosmetics z, brand-wide, ODM contract manufacturing services. AI smart matches the 500+ certification contract manufacturing plant, providing a one-stop package from formulation R&D to regulatory compliance (EU / US FDA) covering skin, makeup, sheet mask, serum, eye patch, category, category, etc.

Core functions

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  • Z / eye patch / serum / z all category

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