Phone:
732.560.1366
Fax:
732.560.9321
Email:
tomer@tomerlabs.com

CHROMAK RESEARCH, INC.

Professional Analytical Research and Development,

Routine Testing, HPLC Training and Consulting Services

350 CAMPUS DRIVE, SOMERSET, NEW JERSEY 08873

PHONE: (732) 560-1366        FAX: (732) 560-9321

 

Services Provided by Chromak Research, Inc.

 

RESEARCH AND DEVELOPMENT

·         Analytical methods development for new drugs.

·         Separation, quantification and identification of impurities and degradation in products.

·         Methods development and validation reports.

·         Development of stability indicating methods for new and commercial products.

·         Development and validation of dissolution methods.

·         Modification of existing methods.

·         Stabilization of new and experimental formulations.

·         Investigation and characterization of commercial formulations.

·         Ruggedness testing.

·         Collaborative testing.

·         Cleaning methods development and validation.

·         Troubleshooting of difficult to reproduce USP, NF test methods.

 

ROUTINE TESTING

·         USP, NF, AOAC, FCC testing.

·         Product release testing.

·         Confirmatory testing.

·         Raw materials and excipients testing.

·         Dissolution testing of new and commercial products.

 

STABILITY STUDIES

·         Stability testing of clinical supplies.

·         Stability studies of new drugs for IND/ NDA/ ANDA filing.

·         Stability testing of marketed products.

·         Stability studies of re-formulated products.

·         Stability testing of product manufactured in alternate equipment.

·         Stability monitoring of products with new packaging and container closure systems.

 

DOCUMENTATIONS

·         Prepare Standard Operating Procedures (SOP’s).

·         Prepare Chemistry, Manufacturing and Control (CMC) section of IND, NDA, ANDA.

·         Prepare Biopharmaceutic section of ANDA, NDA.

 

HPLC TRAINING

·         Hands on training in HPLC, GC, TLC, UV, IR and Dissolution.

·         FDA slide/ Tape Presentation on dissolution.

·         Audio video presentation on HPLC, GC, weighing, pipeting and pH.

·         Advanced training in methods development, methods validation and report writing.

·         cGMP, cGLP.

·         Tips on how to minimize retest and resample.

·         How to write Investigation Reports.

·         Notebook and Record keeping to meet FDA and Patent requirements.

·         Video audio presentation on FDA inspection.

 

Training design is similar to the “Analyst HPLC Training and Certification Program” used by the FDA in their division of Drug Analysis to train FDA chemists.

 

AUDITS

·         Audit of quality control laboratory, Analytical Research laboratory, Bio-analytical laboratory and laboratory engaged in stability and clinical testing.

 

CONSULTING

·         Research and development, cGMP, GLP, ICH guidelines, Special Projects, SOP writing and IND, NDA/ ANDA filing. Services are provided by professionals with extensive experience in the pharmaceutical industry. Services are specifically geared to meet the need of individual client companies. Chromak Research functions as an extension of client’s resources as and when needed.

 

CLIENTS INCLUDE:

Bristol Myers Squibb              Solvay Pharmaceuticals          Mead Johnson             Pfizer

Novartis          Estee-Lauder               Cosmair           Berlex Laboratories     GARY NULL

GSK                Merck              Dupont            LÂ’Oreal

 

PERSONNEL

Laboratory services are provided under the direction of Dr. Onkar S. Tomer Scientific and Technical Director of Chromak Research. Dr. Tomer received his MS in Organic Chemistry and Ph.D. in Analytical Chemistry from Rutgers University. He has over twenty five years of experience in pharmaceutical and healthcare industry. Dr. Tomer was associated with leading pharmaceutical and healthcare companies including Carter-Wallace, Pennwalt Pharmaceutical Research, Organon (Div. of Akzo Nobel) and Pfizer. His experience includes pre-formulation, analytical method development, methods validation, stability studies, testing and release of clinical supplies, cleaning validation, analysis of biological fluids, quality control and submission of over twenty IND, NDA and ANDA.

FACILITY

Laboratories are fully equipped with standard laboratory equipment and state of the art analytical instrumentation including HPLC, GC, TLC, UV, IR, Dissolution apparatus, Electrophoresis units, muffle furnace vacuum ovens, stability chambers and HPLC column packing equipment.

 

LOCATION

Chromak Research laboratories are located  at 350 Campus Drive, Somerset near Route 287 (Exit 12) in Central New Jersey, one hour drive from New York and Philadelphia.

 

REGISTRATION AND APPROVALS

  • Registered with U.S. FDA, Registration No. 2248066

  • Approved by New Jersey Department of Education “Laboratory-Hands on Training HPLC

  • Program”, Dr. Tomer as Director and instructor.

  • U.S. DEA and EPA.

  • New Jersey Department of Health.

 

CONFIDENTIALITY

Confidentiality of information is maintained strictly in compliance with the instructions of the sponsor. No information is released without prior written permission from sponsor.

For further details, please contact Dr. Tomer at:

(732) 560-1366

(732) 560-9321 Fax

E-mail: tomer@tomerlabs.com

 

 

Reasons To Consider Chromak Research For All Your Testing, Analytical Research & Product Development Needs

  

  • Professional staff with over 60 years of combined experience in all areas of pharmaceutical Research and Development.

  • State of the art equipment and capabilities to provide full service.

  • FDA inspected facility with no 483 observation.

  • Accurate and prompt turnaround time.

  • Capability of handling small and large projects on a priority basis.

  • Develop and validate more analytical methods than any other laboratory of equivalent size.

  • Laboratory is used by the NJ Star-Ledger, 10th largest newspaper in the US, and by ABC-TV.

  • Ideally located between the NJ, NY and PA airport (less than 1 hr. drive) and between NY City and Philadelphia.

  • Rush service: same day service, or 2-3 days turnaround available.

 

Laboratory Testing Services
 

            Pharmaceutical Research & Development

 

 

CURRENT FEE SCHEDULE 2008

 

HPLC

ISOCRATIC*

            Compendial method …$120

            Client Method ….$145

 

GRADIENT*

            Compendial method …$170

            Client Method….$195

 

METHOD DEVELOPMENT

            …..$150 per man hour

                                                                                    (estimate 40-80 hours)

 

METHOD VALIDATION

            …..$150 per man hour

                                                                                    (estimate 60-100 hours)

 

GAS CHROMATOGRAPHY (GC)*

            Compendial method …..$120

            Client Method …..$145

            OVI (method I) ….$300

                    (method IV)…..$350

 

TLC

            Compendial/Client method …..$155

 

DISSOLUTION

            APPARATUS I , II AND III

            MANUAL OR FULLY AUTOMATED

                        Single Time Point …$400 per test

                        Enteric Coated …..$600 per test

                        Dissolution profile …$100 per interval

                        Dissolution method development ….$120 per man hour

                                                                                                        (estimate 60-120hours)

 

STABILITY STUDY

            Stability Chamber 25OC/60%RHÂ …$20 per unit

            Stability Chamber 40OC/75%RH …$25 per unit

            Stability Chamber 37OC/75%RH …$25 per unit

 

SPECTROPHOTOMETER

            UV/ Visible …..$150 per sample

            IR ….$150 per sample

 

RAW MATERIAL TESTING

            …Prices available upon request

 

 

 

FOOTNOTES:

1.      *A fee for system suitability is applied for HPLC and GC analysis.

2.      No charge for UV analysis of dissolution samples.

3.      A $80 per sample charge will be applied to HPLC analysis of dissolution samples.

4.      No charge for stability storage for long-term stability samples.

5.      Method validation cost may vary based on clientÂ’s protocol.

6.      *A fee for sample preparation may be applied depending on sample matrices.

7.      Discount is available to high volume customers.

8.      Prices are subject to change without notice.

9.      Credit term is net 30 days.

 

Chromak Research Inc., 350 Campus Drive, Somerset, NJ 08873     Tel. 732-560-1366   Fax 732-560-9321

 

 

Laboratory Testing Services
Herbs & Dietary Supplements

 

FEE SCHEDULE EFFECTIVE SEPTEMBER 2007

 

Any Herbal Identification and...     1st Sample

Benchmarking …   $300

Alfa Alfa (Protein) …   $160

Aloe (Aloin) …..  $285

Althaea Officialis……...    $290

Andrographis Paniculata (Andrographolides) ..…      $290

Androstene Diols & Dione ……   $295

Artichoke (Caffeylquinic acids) …    $270

Artemisinin                                                                                           $275

Astraglus (polysaccharides) ……..    $290

Atractylus Root …….  $290

Becopa Monniera Ext. (Becosides) ……...   $290

Betaine HC1 ….. $275

Bilberry (Anthocyanosides) …..    $280

Biopterin …...  $295

Bioprine (Black pepper Ext.) …   $295

Black Cohosh (Triterpene Glycosides) ….$290

Bladderwrack (fucosterol) …   $290

Boswellia (Boswellic Acid) …..    $290

Bromelain (Pineapple) ….     $300

Butterbur (sesquiterpenes)                                                                    $285

                (pyrrolozidine Alkaloids)                                                       $365

Carbohydrates ( mixture/single)                                                 $220

Catnip … Â…Â…... $285

CatÂ’s Claw (total alkaloids) …..    $290

Cayenne (Capsaicin) ….   $275

Chamomile (Apigenin) ….    $290

Charantin …...  $285

Citrus Bioflavinoids ….     $290

Chitosan …  $280

Choline Bitartrate                                                                                  $290

Chondroitin Sulfate, A, B or C ….    $290

Chromium Picolinate …    $290

Ciwujia (Eluthrosides) …..    $295

Coleus Barbatus (Forskolin) ….   $295

Collagen Type II …...   $290

Comfrey (Pyrrolizideine alkaloid)..…...     $365

Cordyceps (cordycepin) …  $290

Coenzyme Q-10 …  $290

Cranberry (Cyanidin/ peonidin, total anthocyanidins) ….        $290

Cranberry Acids …  $280

Creatine …. $280

Cucurbitacin …..  $290

DevilÂ’s Claw (Harpagosides) …   $290

Diosgenin …..  $285

DHEA …...  $290

Dibencozide …..  $280

Digitalis (digoxin) ….    $295

DMAE …..  $280

DongÂ’Qui (Ligustilide/ Ferrulic acid)…..       $280

Echinacea (Echinacosides/ Cichoric acid/ Phenols) ….      $290

Elderberry (Anthocyanidins)….     $280

Ellagic acid ….  $285

Ephedra (Ephidrine)…..    $280

Epimedium (Icariin)                                                                               $320

Eschschoizia California….     $285

Evening Primrose Oil (GLA/ Authenticity) ….        $290

Eye Bright…..  $295

Feverfew (Parthenolide)….   $295

Fungal Lipase                                                                                       $375

Garcinia Cambogia (Hydroxy Citric Acid, (-) HCA)…      $295

Garlic (Allicin)…$295

Gentisic Acid ….   $295

Ginger (Volatile Oils)…    $295

Ginseng (ginsenosides)…..    $290

Ginsen Siberian (Eleuthrosides B & E)…..$290

Ginko (Ginkolides or Flavonoids/ Terpenoids)…..$295

Ginkgolic Acid...$295

Beta-Glucans …..  $290

Glucosamine and/ or Pot. Sulfate Salt …...     $280

Glutathione ….  $295

Glycyrizine (in Licorice) …    $295

Goldenseal (Hydrastine, Berberine) …...    $295

Gold Thread (Berberine, Palmatine...    $290

Gotu Kola (Asiaticosides)...   $290

Grape seed Ext. (Proanthocyanidins)...    $290

Guarana (Caffeine)...  $285

Gymnema Silvestre (Gymnemic Acid)...     $290

Hawthorn (Vitexin-2”-rhamnoside, Hyperoside)...      $290

Hops (Alfa and Beta Acids)...   $285

Hops Strobiles (1-Hexacosanol)...   $290

Horse Chestnut [Aescin (Escin), Aescilin(Esculin)]...        $295

Horsetail (Silica)...   $190

Hot Peppers (Capsaicinolids)...   $290

Humulus Lupulus (Humulone)...      $295

Hydroxy Methyl Buteric Acid (HM),..     $280

Inositol                                                                                     $290

Jiaogulan (Gypenisides)                                                             $290

Kava Kava (kava lactones)...   $290

alpha-Keto-isocaproic Acid...   $295

alpha-Keto-gluconic Acid...   $295

Kola Nut (Caffeine & Theobromine...    $290

Licorice (Glycyrrhizic Acid)...    $290

Lime Oil...  $290

alpha-Lipoic Acid...   $295

Lavastatin (Red Rice Ext)....   $350

Lutein (Carotenoid Alcohol)...    $295

Lycopene... $295

Mahauang (Ephedrines)...   $295

Melatonin...  $290

Methylsulfonylmethane (MSM)...     $295

Milkthistle (Silymarin complex)...      $295

Mucopolysaccharides…...  $290

Muira Puama...  $295

Pancrelipase (Amylase, Protease, Lipase...    $800

Papaya (MCU)                                                                                    $375

Passion Flower (flavonoids)...    $270

Pau D’Arco (Lapachol)...  $270

Peppermint...  $270

Peroxidase                                                                                           $230

Phophatidyl salts...   $295

Pine Bark, Leaf (Proanthocyanidins/ Vit K3)...     $295

Pomegrante Seed Oil (complete)                                                           $1480

Poppy Whole Plant...   $295

Pycnogenol...  $290

Pygeum (sterols)...   $290

Pumpkin seeds (fatty acids)...    $290

Red Yeast Rice                                                                                    $300

Resveratol...  $290

Rose Hips (Ascorbic Acid)...   $290

Rosemary...  $295

Rosemaric Acid...  $295

Royal Jelly (10-HAD)...   $290

SAMe (s-adinosylmethionine p-tosylate...     $290

Saw Palmetto (Fatty Acids/ Sterols...    $295

Senna Leaves (Sennoside A &...   $300

Shatavari (shatavarins)                                                              $290

Shavegrass (Silica)...   $250

Soy/ Kudzu (Isoflavines)...    $290

Spirulina...  $295

Stevia (Stevioside)...   $290

St. Johnswort(Hypericin)...    $260

Superoxide Dismutase...   $260

Tea (Polyphenols, Caffeine)...    $280

Thuja plicata...   $290

Tomato Extract (lycopene)...    $295

Tribula Terrestris (Saponins)...    $295

Turmeric (Curcumin)...    $290

Uva Ursi (Arbutin)...   $290

Valerian (Valerenic Acid)...    $290

Vitex Agnus Castus (Agnuside or Aucubin)...      $290

Wheat Grass...  $215

Wild Yam Root (Diosgenin)...    $290

Willow Bark (Salicin)...$290

Yeast Extract ( Acids,sugars, proteins, each)                                         $250

Yohimbe... $290

Plant DNA/ RNA...Upon request

 

PESTICIDES/ HERBICIDES

Chlorinated pesticides, screening...    $290

Herbicides, screening...   Â…Â…... $290

Organophosphorous pesticides, screening...    $290

Individual pesticides/ herbicides...     $250

 

SOLVENT RESIDUES

Acetone... $260

Isopropyl Alcohol...   $260

Ethylene dichloride...    $260

Methylene dichloride...    ... $260

Hexane...$260

Chloroform...$260

Dioxane...  $260

Ethylene oxide...$265

Perchlorethylene...$265

Solvent Residue Screening (OVI, VOC)...    $300

 

SUGARS/ CARBOHYDRATES/ ORGANIC ACIDS

Individual sugars...   $200

Profile of common sugars...    $380

Total sugars...  $280

Individual Organic acids...    $260

Profile of common organic acids...$380

 

AMINO ACIDS AND PROTEINS

Free amino acids...  $265

Bound as protein, amino acids...$295

Individual amino acids...$260

Nucleotides...$280

Soluble proteins...   $120

Total nitrogen...  ...$120

 

FATTY ACIDS

Fatty acids composition...   $250

Fatty acids cis and trans Isomers...$220

Iodine value...  $120

Saponification value...    $120

Hydroxyl/ Acetyl value...     $135

Glycerides...  $130

Phospholipids...  $120

 

VITAMINS

Vitamin A, Retinols...$280

Vitamin B1, Thiamin...    $285

Vitamin B2, Riboflavin...    $280

Vitamin B6, Pyridoxine...    $280

Vitamin B12, Cyanocobalamin...$290

Vitamin C...$280

Vitamin D...   $290

Vitamin E...$290

Vitamin K3...   $290

Folic Acid...  $290

β-Carotene...$290

 

ENZYMES

Amylase                                                                                               $475

Bromelain                                                                                             $325

Lipase                                                                                                  $375

Papain                                                                                                  $375

Pepsin                                                                                                  $375

Protease                                                                                               $420

Milk Clotting Units                                                                                $375

 

This list reflects only a fraction of our analytical capabilities. We provide analytical services to large and small pharmaceutical companies from FDA submissions to raw material testing.

 

FOOTNOTE:

1.      A minimum set-up fee for HPLC, GC may be applied to the first sample.

2.      A fee for sample preparation may be applied for samples with complex matrices.

3.      Discount available to high volume customers.

 

 

Chromak Research Inc., 350 Campus Drive, Somerset, NJ 08873     Tel. 732-560-1366   Fax 732-560-9321

  

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Chromak Research Inc. 2004