Pharmaceuticals
We partner with manufacturers, packagers, raw material suppliers, and formulators during each stage of the drug development process to assist with pharmaceutical and chemical analysis.
Pharmaceutical Analytical Testing Services includes:
- Vendor qualifications
- Finished product
- Release Testing
- Stability Testing
- Cleaning and Process validation
- Method Development
- Method Validation
- Method Verification
- Method Transfer
Analytical Testing includes:
- Raw materials, excipients
- Active pharmaceutical ingredients (APIs)
- Packaging, solvents
- Finished dosage forms
- Other process reagents
OTC
We partner with leading OTC testing and development labs to ensure monograph compliance to the U.S. Pharmacopoeia (USP) and European Pharmacopeia (Ph. Eur.).
Services Provided OTC manufacturers, scientists, and formulators:
- Method Development and Validation
- Stability Programs
- Monograph Testing
- Formulation/Process Development
- Contaminant ID & Failure Analysis
- Bio equivalency testing
- Assistance in formulating and improving National Brand Equivalent (NBE) products.
- Analytical Testing in the OTC product development stages to ensure a streamline the release of a stable and safe product in the market and meet cGMP and
- Identify any contaminants or root causes for failing products
APIs, Raw Materials, and Excipients
We partner with our manufacturing clients to test Raw Materials, Active, Active Pharmaceutical Ingredients (API), Excipients, as well as their Finished Products.
The FDA requires that manufacturers of drug products ensure that they are using good quality raw materials that are pure and identifiable. This is a critical step in the manufacturing process to ensure that the finished product is suitable for its intended use.
Consumer Products
We partner with our clients to address all their issues related to their products such as:
- The safety of their product
- Quality Control
- Out of Specification Analysis
- Formulation and/or Deformulation
- Regulatory Compliance
- Product Development
Our Services of Product Testing includes:
- Methods Development and Validation for product development
- Batch to Batch Testing for finished products
- Formulation and Deformulation of products
- Out of Specification Analysis and Troubleshooting
- Forced Degradation Analysis
- Stability Testing
- Comparative Analysis
- Litigation Services
Chemical
We have over 20 years of chemical testing and analysis experience, and we apply our Total Quality Assurance expertise to pharmaceutical and consumer products.
We partner with companies of all industries to ensure their chemical testing and analysis complies with regulatory and safety requirements.
To better understand the quality and composition of chemical substances and materials used in products, and in manufacturing processes, chemical testing and analysis is imperative for regulatory compliance.
With 40 years of experience, Scientech has expert industry knowledge in applying the most relevant methodology towards successful chemical testing. We use advanced analytical instrumentation and techniques to address your projects.
We comply and perform testing protocols in accordance with the following standards in order to develop tailored analytical methods and performing method validation for your specific testing requirements:
Elemental Analysis
Metal impurities are introduced into pharmaceutical products and dietary supplements from raw materials, catalysts, equipment, and the environment. Changing regulatory requirements now require manufacturers to determine elemental impurities in new and existing products. These analyses include metals analysis and the analyses of inorganic, aqueous, and non-aqueous materials.
Scientech utilizes the instrumental techniques of Inductively Coupled Plasma-Mass Spectrometry (ICPMS). ICP is a very high temperature excitation source that efficiently desolates, vaporizes, excites, and ionizes atoms. A mass spectrophotometer is utilized to separate and detect the ions (ICP-MS). The intensity of this emission or ions is indicative of the concentration of the element within the sample. The use of ICP will allow specific, multi-element determinations with sensitivities down to the part-per billion (ppb) levels.
- cGMP
- GLP
- EN
- BS
- ASTM
- DIN
- JIS
- AFNOR
- ASME
- ANST
Scientech is capable of assessing levels of elemental metals / elemental impurities in raw materials, in-process formulations and finished pharmaceutical and provides analytical services to support compliance with Quality Control requirements on label-claim or demonstrating control of trace-level elemental impurities as published in the European Pharmacopoeia (EP) chapters 5.20 and 2.4.20 and the United States Pharmacopoeia (USP) general chapters <232> and <233>.
Cleaning Validation Analysis
Utilizing our expertise and sophisticated instruments we are able to detect contamination of equipment. A swift response could save our clients time, money, and scrutiny from regulatory agencies.
Nutraceuticals
We partner with Nutraceutical manufacturers and ingredient suppliers to provide quality testing services for the nutraceutical industry.
Nutraceuticals are dietary supplements. Ingredients for nutraceuticals are sourced from many different manufacturers and from multiple countries of origin.
We assist our Nutraceutical partners to ensure against adulteration at all stages of their production process from supply chain to finished product.
Analytical Testing for Nutraceuticals Include:
- Testing ingredients for quality and purity according to established standards, such as the USP-NF and FCC, helping manufacturers and suppliers protect the quality of ingredients
- Testing reference standards helps authenticate the quality and purity of dietary supplements and finished products
Cosmetics
The FDA requires cosmetics to be safe when consumers use them according to directions on the label, or in the customary and/or expected manner. Product testing is just one way manufacturers ensure the safety of their cosmetic products.
Type of Products Tested:
- Skin creams
- Lotions
- Perfumes
- Lipsticks
- Fingernail polishes
- Eye and facial make-up
- Sunscreens
- Shampoos
- Permanent wave solutions
- Hair colors
- Toothpastes
- Deodorants
- Materials used as components of cosmetic products
Cannabis Derived Products
The cannabis industry is growing rapidly. Cannabis testing regulations are constantly evolving with the industry as it grows and gains acceptance.
Potency Testing
- Levels of cannabinoids in a product.
- Cannabis contains over 100 different cannabinoids that have been identified in the plant.
- Each cannabinoid has a distinct effect on the endocannabinoid system of our bodies thereby having different beneficial effects.
Contaminants Testing
- Heavy Metals Testing
- Microbial Testing
- Pesticides Testing
- Residual Processing Solvent
Beauty Care and Personal Care products
We partner with cosmetic manufacturers, packagers, raw material suppliers, and formulators during each stage of the product development process.
We are following changes introduced in the Safe Cosmetics and Personal Care Products Act of 2019 (HR 4296) which includes provisions that would require more comprehensive ingredient labels and ban the use of animal testing for cosmetic products.
Cosmetic Analytical Testing Services include:
- Raw materials testing
- Vendor qualifications
- Finished product testing
- Release testing
- Stability testing
- Cleaning and Process validations
- Method development
- Method validations
- Method Verification
- Method Transfer
Testing Cosmetic Ingredients
- Quality and purity by USP-NF and FCC, help manufacturers and suppliers protect the quality of their products
- Stability Testing of cosmetics for physical, chemical, microbial, and packaging characteristics
- Reference Standards
Wellness
We partner with manufacturers of wellness products to ensure the safety and quality of their products.
Distinguish your wellness product and your brand by ensuring that your product has undergone rigorous testing for:
- Safety
- Stability
- Potency
- Label claims
Whatever your product line, we cover:
- Nutraceuticals
- Supplements
- Vitamins
Our Comprehensive Lab Services include:
- Stability & Shelf Life
- Ingredient & Contaminant ID
- Packaging Compatibility
- Method Development & Verification
- Quality Control
- Quality control ensures batch-to-batch consistency
- Establish shelf life
- Verify the composition and ingredients
- Testing & Verification Service Specialties
- Wellness Product Development
