Our Services

Pharmaceuticals

ULPL offers comprehensive analytical support to QA/QC and pre-clinical testing to pharmaceutical, OTC, and biotech industries. Ullmann Analytical Laboratories conducts USP/NF and BP monograph testing, meeting full FDA/GMP requirements (21 CFR). ULPL also provides testing according to EP, PF, or other customer methods if requested.

Ullmann Analytical specializes in testing active drug substances and excipient ingredients in analgesic, anti-inflammatory drugs, vitamin and mineral supplements. ULPL’s pharmaceutical science group performs a variety of chemistry and microbiology analysis for finished products and raw materials according to USP/NF.

List of our Personal Care Analytical Services:

  •  Cleaning Validation and Contamination Studies on Production Equipment Testing Process Validation Testing.
  •  USP <51> Antimicrobial Effectiveness Testing (Preservative Effectiveness).
  •  USP <61> Microbial Enumeration Test (Microbial Limit)
  •  USP <191> General Identification Tests.
  •  USP <197> UV Identification and Assay and USP <201> Thin-Layer Chromatography Identification and Purity Test.
  •  USP <211> Arsenic, USP <231> Heavy Metal, USP<261> Mercury, and USP <251> Lead Limits.
  •  USP <467> Residual Solvents.
  •  USP <643> Total Organic Carbon for Production (High Sensitive Catalyst).
  •  USP <731> Loss on Drying, USP <281> Residue on Ignition and USP <921> Karl Fischer Moisture Analysis.
  •  USP <786> Particle Size by Sieve, USP <831> Refractive Index, USP <841> Specific Gravity, USP <781> Specific Rotation, and USP <911> Viscosity by Kinematic and Rotational Processes.
  •  Stability Studies (Shelf Life 2 Years, 3 Years).
  •  Dissolution Testing for Drugs, luding Convention, Extended Release for Capsule, Spin, Basket, Slow-Release Tablet, and Sublingual FTIR Identification and Quantitation.
  •  GC for Assay and Purity of Drug and Excipient.
  •  HPLC Quantitation for Assay and Chromatographic Purities.
  •  USP <1225> Method Development and Method Validation.
  •  Potentiometric Titration.
  •  Flash Point, USP <741> Melting Point.

Cosmetics Laboratory Testing

At Ullmann analytical lab, cosmetic analysis is one of our primary areas of expertise. Our cosmetic scientists are fully staffed for seven days of operation. Ninety percent of our analyses are performed on a daily basis. Our high quality instruments such as liquid chromatography, gas chromatography and ion-chromatography are used for the assay and purity of active ingredients.

All raw materials must be tested:

  •  Free of pathogenic microbiological contamination. (Microbiology page linked).
  •  Free of Inorganic impurities such as lead, arsenic, mercury, and heavy metals as per USP, FCC and CTFA requirements. (Pharmaceuticals arsenic, etc. linked).

Below maximum allowable limits of organic contamination such as residual solvent, 1, 4-dioxane, formaldehyde, phthalate, and nitrosamine.

Cosmetic Labeling Requirements: Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anti-cavity toothpastes (e.g., “fluoride” toothpastes), suntanning preparations intended to protect against sunburn, anti-perspirants that are also deodorants, and antidandruff shampoos.

List of our Cosmetics Analytical Services:

  •  Antioxidant, Skin Care Products.
  •  Color Additives Testing.
  •  Fragrance and Cologne.
  •  Moisturizers, Emulsifiers, Surfactants, and Stabilizers.
  •  Nail Polish Testing.
  •  Preservative Additives Analysis.
  •  Skin Care and Skin Therapeutic Testing.
  •  Soap and Shampoo Testing.
  •  Sunscreen-Suntan Product Testing .

Microbiology Laboratory Testing

ULPL offers a variety of microbiological services, such as testing and analyzing products ranging from raw materials to finished goods from a broad range of industries. Our microbiology department is staffed with scientists experienced in testing AOAC, FDA, USP, and other internationally harmonized methods of microbiological testing.

ULPL has provided microbiological services to pharmaceutical, disinfectant, cosmetic, personal care, over-the-counter, dietary-supplement and many other industries.A more detailed list of the new USP <61> and <62> can be found below. Effective May 2009, the new USP <61> and <62> provide harmonization to the existing European Pharmacopeia method for testing non-sterile pharmaceuticals. This includes over-the-counter (OTC) and personal care products. The original total mictobial limits USP <61> underwent significant changes and split into two part new parts, USP <61> and <62>.

USP <61> Microbial Enumeration Tests such as total aerobic microbial count (TAMC), and total yeast and mold count (TYMC). The Microbial Enumeration Tests' changes lude new pass/fail criteria, longer ubation durations, and the disallowing of retests. Negative control is now required every time that the product is tested. Organism validation in TSA plates have changed to Staphylococcus, Pseudomonas, and Bacillus subtilis.

USP <62> Microbiological Examination of Non-Sterile Products: Tests for Specified Microorganisms. The modifications on microbiological medias for specific pathogens like Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Clostridia, bile–tolerant Gram-negative bacteria, and Candida albicans. Critical changes have been made to enrichment broth, ubation temperatures and ubation duration. Organisms such as Candida albicans, Clostridia species, and bile-tolerant Gram-negative bacteria may be required to be tested depending on product type per FDA and USP monograph. Negative control is required everytime that the product is tested.

List of our Microbiological Services:

  •  Cosmetic & Personal Care Microbiological Laboratory Services
  •  Pharmaceutical Industries Microbiological Laboratory Services.
  •  Disinfectant Services.
  •  Nutritional and Dietary Supplement Microbiology Testing.

Fruits Laboratory Testing

ULPL Food Testing Service - Food Product Testing involves multiple steps of sample preparation and tedious extraction. Due to the complicated nature of the food product matrice, our food testing group performs the quality control testing on food raw material and finished goods from sweet tooth snacks such as cake, cookies, candy, yogurt or ice cream; starch carbohydrate sources such as rice, noodles, and pie; beverages such as juice, mixed drinks, wine or beer.

Ullmannlab has implemented continuous training on laboratory techniques, instrumentation, technical knowledge, preparation and extraction skills. Ullmann Laboratory performs Raw Material Quality Testing according to published FCC (Food Chemical Codex published by USP) and UNICEF FAO published methods.

List of our Cosmetics Analytical Services:

  •  Nutrition Label Claim (after clicking this following matter should appear on the screen).
  •  Food Chemical Codex (FCC) Food Grade Testing (after clicking this following matter should appear on the screen).
  •  Contamination Testing in Raw Materials as Part of Quality Control(after clicking this following matter should appear on the screen).
  •   Food Product Testing on Finished Goods (after clicking this following matter should appear on the screen).

Nutritional Label Claims

The Nutritional Labeling and Education Act (NLEA) of 1990 mandated nutrient labeling on almost all foods and food supplements sold in the U.S.

The trans fatty acid rule was added to Nutrition Facts panel compliance, effective from January 1, 2006. ULPL adopted AOAC International's and other companies' published equivalent methods for nutritional labeling.

This includes vitamin analysis by HPLC, cholesterol by gas chromatography, fatty acid profile, and methyl ester gas chromatography.

Proximate Analysis:

  •  Calories
  •  Moisture
  •  Protein
  •  Fat
  •  Ash

Nutrition Facts Label package listed below

Calories Cholesterol Vitamin C
Calories from Fat Dietary Fiber Sodium
Protien Saturated Fats Iron
Carbohydrates Total Fat Calcium
Sugars Vitamin A (Retinol and Beta carotene)
Monounsaturated Fats Trans Fats Potassium
Polyunsaturated Fats Other Carbohydrates

Food Chemical Codex

Food Chemical Codex (FCC Food Grade Testing)

  •  Identification by color reaction, precipitation, TLC fingerprint match, FTIR spectra or UV/VIS spectra.
  •  Heavy metals (i.e. Pb), arsenic, mercury not more than mg/kg specification for food grade.
  •  Physical property tests such as specific rotation, specific gravity, refractive index, and melting range.
  •  Loss on drying, Karl Fischer moisture test, residue on ignition, and total ash.
  •  Volatile content, distillation range, solidification point, readily carbonizable substances.
  •  Color (APHA), chlorophyll, cold test and cloud point.
  •  Fats and oil testing: saponification value, acid value, iodine value, peroxide value, ester value, or fats and oil products.
  •  Fatty acid composition for fats and oil.
  •  Solubility in oil, alcohol, and water, etc.
  •  GC, HPLC assay and impurities study.
  •  Es1qsential oil and flavor test for aldehydes, esters, phenol free, UV absorbance, and volatile content.
  •  Carbohydrate and starch group test for inverted sugars, reducing sugars, acetal groups.
  •  Sugar and sugar alcohol carbohydrate profiles by HPLC.
  •  Chewing gum base test for quinine, residual styrene, etc.
  •  Color FDC test for leuco base, total color, TLC profiles, and HPLC impurities.

Contamination

Contamination testing in raw material as part of quality control

  •  Microbial testing in food products for pathogen microbes present such as Escherichia coli, Salmonella, Staphylococcus, Pseudomonas. Microbial enumeration to assure food quality safety for fruits, vegetables, and dried products.
  •  Egg products should check for Salmonella and Escherichia coli contamination.
  •  Mycotoxin testing in raw food materials such as aflatoxin for rice, corn, peanuts and other nut products, or DON and petulin for fruits and juices, etc.
  •  Artificial antioxidant in oil such as TBHQ, BHT, BHQ, and benzoic acid.
  •  Artificial color in flour and fruit powders, such as corn rice flour and colored fruit powder. Testing on FDC yellow 5, FDC red 40, and other Azo colors using FDA color testing method.
  •  Prohibited products present in food raw material luding melamine, dioxane, phthalates, and nitrosamine.
  •  Fats and oil testing: saponification value, acid value, iodine value, peroxide value, ester value, or fats and oil products.
  •  Diethylene glycol in glycerol or glyceride.
  •  FCC methods state that raw vitamin materials are required to check for purity.
  •  For changing a new vendor or supplier, some raw materials in FCC monographs required testing for trace contamination of lead, arsenic, mercury, and cadmium; this is to assure there are no poisonous or toxic effects, and therefore safe for human consumption.
  •  Moisture by LOSS ON DRYING and Karl Fisher methods may be necessary, se high moisture content reases the possibility for bacterial and mold propagation.
  •  Testing for other impurities in raw material, for example food alcohol, should not have residual toxic contamination of methanol, acetone and Isopropyl alcohol.
  •  Sugar and sugar alcohol must check for purity such as glucose, dextrose, sorbitol manitol and maltitol.
  •  Dried food sources such as fish or anchovies should check for histamine or other amines, se the presence of histamines are a sign of spoiled fished protein.
  •  For raw materials not listed in FCC, check the USDA and FDA food safety suggestions.

Finished Goods

Food product testing on finished goods uses methods from USDA, AOAC and FDA food additive methods.

Partial list of the food finished goods testing as follows:

  •  Preservative testing such as parabens.
  •  Cyclamates as artificial sweetener 21 CFR 189.135
  •  Caffeine, sodium benzoate, and sodium saccharin in sport and soda drinks.
  •  Antioxidants such as BHT, TBHQ, BHQ, HMBP, THBP, NDGA etc. present in butter, margarine, and oil for cooking and salad mixing.
  •  EDTA in crabmeat and mayonnaise.
  •  Epichlorohydrin, dichlorohydrin, such as starch modifying agent 21 CFR 172.892 in corn starch.
  •  Ethoxyquin such as antioxidant 21 CFR 172.140 in chili powder, paprika.
  •  Nitrosamine, phthalate, 1,4-dioxane in food products.
  •  Acetone, benzene, toluene, TCE, chloroform, CCL4, etc. in alcoholic beverages.
  •  Polysorbate content in cakes, ice creams, pastries, cookies etc.
  •  Hydrogen peroxide in flour 21 CFR 178.1005
  •  For jams, juices, sauces, etc., testing on Escherichia coli, Salmonella, and anaerobic Clostridium microbes.
  •  For peanut butter and nuts in cookies, testing on Salmonella, Escherichia coli microbial and aflatoxin is required.

Dietary Supliments Laboratory Testing

As of June 2007, FDA - DSHEA (Dietary Supplement Health and Education Act) is fully implemented and enforces cGMP (current Good Manufacturing Practice) requirements on Dietary Supplements Manufacturing.

DSHEA 1994 definition:
A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredient" must be one or any combination of the following substances:

  •  a vitamin,
  •  a mineral,
  •  an herb or other botanical,
  •  an amino acid, enzymes, or
  •  a concentrate, metabolite, constituent or extract.
FDA /USDA set a maximum daily dose for essential vitamin and nutrient as part of the nutritional label claim.

List of Dietary Supplement (Nutritional Supplement) Testing Services:

  •  Vitamin Testing (Oil Soluble Vitamin, Water Soluble Vitamin).
  •  Mineral Testing (such as Calcium Gluconate, Calcium Citrate, etc.).
  •  Nutrient (Glucosamine, Chondroitin Sulfate, Co-Q10, etc.).
  •  Antioxidant Activity in Natural Products.
  •  Natural Products: Fruit, Berries, Vegetable (Anthocyanin).
  •  Amino Acid (Essential, Non-essential) Essential Fatty Acid (DHA, EPA, CLA, etc.).
  •  Essential Fatty Acid (DHA, EPA, CLA, etc.).
  •  Dietary Enzymes (Amylase, Lipase, B-galactosidase or Lactase, Papain, Bromelein, etc.).
  •  Botanical, Phytochemistry, Herbal Active Testing.
  •  USP <561>, Contaminant and Foreign Substance.

Phytochemicals Laboratory Testing

Another essential component of ULPL,s testing expertise is herbal and nutraceutical products. We routinely analyze natural products for identification, potency, marker quantitation, trace impurities, and organic volatile impurities, as well as many other analyses.

ULPL tests herbal products following the guidelines of only highly respected publications, such as Herbal Compendium, China Pharmacopoeia, German Pharmacopoeia, and others.Additionally, our research staff is continually studying the current trends in natural / herbal products, so when a new herb or extract becomes available, you can be sure that ULPL has a method to test it. We test everything from aloe vera to yohimbe.

Here is a list of our most popular herbs:

Aloe Grifonia
Ashwagandha Gotu Kola
Bilberry Hawthorn
Black Cohosh Isoflavones
Boswellia Serrata Kava Kava
Broccoli Kudzu
Cat's Claw Licorice
Cayenne Pepper Milk Thistle
Citrus Aurantium Passion Flower
Coleus Forskohlii Red Yeast Rice
Cranberry Rhodiola
Echinacea Rose Hips
Ephedra Rosemary
Epimedium Royal Jelly
Evening Primrose Oil Schisandra
Fenugreek Gymnema Sylvestre
Feverfew Siberian Ginseng
Flax Oil Soy
Garcinia Cambogia St. John's Wort
Garlic Tribulus Terrestris
Ginkgo Biloba Uva Ursi
Ginseng Valerian
Golden Seal White Willow
Goldthread Wild Yam
Grapeseed Extract Yerba Mate
Green Tea

Personal Care Laboratory Testing

Ullmann laboratory tests various personal products. We have procedures for antiperspirants, antidandruff products, body washes, antibacterial gels, antimicrobial wipes, oral care toothpastes, and therapeutic products. We test by FDA approved standards, and by foreign standards when applicable for export.

Ullmann Analytical specialty testing scientists also possess great expertise in personal care products. Using state of the art instrumentation, Ullmann laboratory analyzes raw materials and finished goods for potency, purity, and trace residual impurities present in products.

Cosmetic Labeling Requirements: Products that are cosmetics but are also intended to treat or prevent disease, or otherwise affect the structure or functions of the human body, are also considered as OTC (over-the-counter) and must comply with both the drug and cosmetic provisions of the law.

Examples of products which are drugs as well as cosmetics are anti-cavity toothpastes (e.g., "fluoride" toothpastes), hormone creams, suntan or sunscreen preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.

List of our Personal Care Analytical Services:

  •  Antidandruff Shampoo Testing.
  •  Antiperspirant/Deodorant Testing.
  •  Dental and Oral Care Products Testing.
  •  Disinfectant and Sanitizer.
  •  Insect and Mosquito Repellent.
  •  Lice and Insect Repellent.
  •  OTC Antibiotic Personal Hygiene Products Analysis.
  •  Packaging Stability.