ADPEN can assure you of the quality of your raw materials and finished products by providing the best analytical service available.   As a leading independent laboratory providing analytical services worldwide, we can help you keep your products in compliance with the latest requirements and serve as third-party unbiased testing source.   

 

PARTIAL LIST OF PHARMACEUTICAL  ANALYSES

 

Standard Turnaround – 5 Business days turnaround for most analyses, please ask.

 

Raw Materials, Plant Extract, Finished Products, Gel capsules

 

 

SUPPORTING ANALYSES

Standard turnaround – 5 - 7 Business days

                                   

Appearance Only                                                                                                                         

Appearance and Test.

Appearance & Organoleptic.

Appearance & Moisture Only                                  USP <921>                                          

Disintegration Test                                                 USP <2040>  

Dissolution Tests                                                   USP <2040>           

                                                                                 Plus marker compound test         

Weight Variation                                                    USP 2091 & 905                                  

Dosage Uniformity                                                                                                                         

Sample Compositing                                                                                                    

Loss on drying 

Optical rotation                                                      USP

Acidity                                                                  USP

Organic Volatile Impurities Method IV                      USP

Specific Gravity

Moisture

Heavy Metals                                                         FCC/USP

Heavy Metals by ICP                                              Antimony, Arsenic, Cadmium, Copper, Lead,

                                                                            Mercury, Molybdenium, Silver, Tin

Heavy Metals by ICP-MS

Minerals by ICP or ICP-MS

Zinc Amino Acid Chelates                                      ICP or ICP-MS

Microbiological Profile, USP                                   Total Plate Count, Yeast & Mold, E. Coli,

                                                                            Salmonella, Staphylococus.

 

 

RESEARCH & DEVELOPMENT / PRODUCT SUPPORT

 

Method validation and other analyses on request                                                                             

LC/MS/MS confirmation available                                                                                                     

Product Fingerprint by LC/MS

Stability Testing, Accelerated or Real Time.

FT-IR qualitative and quantitative analyses.

                                                                                                                                          

 

ADPEN is an R&D contract laboratory and can develop new analytical methods, can identify or elucidate active ingredients under a research contract format.  For a research contract quote, please call or send a request and information by e-mail, Fax or mail.

                                                                         

 

GENERAL INFORMATION

 

SAMPLE AND SAMPLING INFORMATION

 

Submission of Samples

 

Sample amount needed for analysis depends on test and type of sample.  About 10 grams for powders, at least 36 capsules and tablets, 10 grams for raw material and 20-30 mL liquid extracts.

 

A Chain of Custody or letter with sample list and lot numbers requesting specific analyses, a release specification for the product to be tested (testing specifications) and a Purchase Order or Purchase Order number should be included with samples.  Samples can be sent overnight by overnight carriers, our facility is located next to Airborne Express.

 

Sample Retention

 

Samples may be retained for a maximum of 6 months or as required by FDA after results are reported unless otherwise requested.

 

PAYMENT INFORMATION

 

For single samples, payment must be submitted with the samples unless a contract is made.  For regular clients a purchase order should be submitted with samples.  For multiple samples, 50% with the samples and 50% at completion of analyses.  For overseas testing, please submit samples with payment in full by wire transfer.  Invoices will be payable and due 14 days from invoice date. Monthly service charge on past due balances 1.5%.   For contract information or additional information please call Maria. 

 

METHODS OF ANALYSIS

 

ADPEN  uses the most appropriate methods for each analysis.  The methods used are AOAC, FDA, USP and other approved official methods; methods developed and validated in-house; and other validated methods.  Methods may have been modified to improve efficiency, reproducibility and recovery. 

 

ACCREDITATION

 

ADPEN is a contract laboratory operating under FDA, EPA Good Laboratory Practices (GLP) & cGMP.   We also follow EP, JP, OECD, WHO, USP and other guidelines.  We have been inspected by the EPA for Good Laboratory Practices requirements and by FDA for cGMP compliance and have passed inspection and given acceptance letters.  The FDA and EPA does not certify independent laboratories.  Our EPA ID number is FL 0000121038.  Our FDA Registration Number is 1064435. We are also certified as a CLIA laboratory and to handle drugs by DEA..  We have been inspected by the Quality Assurance Units of our major sponsors on a regular basis.

 

Call us or e-mail us for information on contracting analytical services.  Overseas clients, please send e-mail or Fax with questions and request for information.