Stability Study Questionnaire

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* 1. Participant Information

Name:

Company:

Member Number:

Email Address:

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* 2. Organization Type

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* 3. Survey Date

Stability Studies Survey

Date

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* 4. Drug Name: (As Per Sample Label)

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* 5. Active Pharmaceutical Ingredients (API) / Analytes and Concentrations (if additional APIs / Analytes & Concentrations are needed, enter information into the "Notes" section found at the end of the survey):

API / Analyte & Concentration

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* 6. Dosage Form:

Capsule/Tablet

Cream/Lotion/Ointment/Gel

Solution

Suppository

Suspension

Other (Please Specify)

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* 7. Route of Administration:

Inhalation

Intramuscular/Intravenous/Subcutaneous

Intrathecal

Irrigation

Nasal

Ophthalmic

Oral

Otic

Rectal/Vaginal

Topical/Transdermal

Other (Please Specify)

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* 8. Length of Study (Desired BUD):

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* 9. Time Points to be Tested:

T - 0

T - 7

T - 14

T - 30

T - 45

T - 60

T - 75

T - 90

T - 120

T - 150

T - 180

Other (Please Specify)

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* 10. Sterile or Nonsterile

Sterile

Nonsterile

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* 11. Storage Condition:

Room Temperature

Refrigerated

Frozen

Accelerated

Other (Please Specify)

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* 12. How many Lots are to be tested?

1 LOT

2 LOTS

3 LOTS

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* 13. Maximum Batch Size:

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* 14. Container Type: (E.g. Vial, Syringe, Etc.)

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* 15. Container Size:

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* 16. Container Fill Volume:

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* 17. Does the formula contain an antimicrobial preservative? (Select All That Apply)

*Yes, I would like to assay the preservative.

Yes, but I do not want to assay the preservative.

No, formula does not contain an antimicrobial preservative.

*Note: If you would like to assay the preservative, document the preservative, its concentration, and associated specification.

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* 18. Is the product a Multidose Vial?

Yes

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* 19. USP <85> Bacterial Endotoxin Test:

DOSING INFORMATION

Maximum Dose (mL/hr):

Average Weight of Patient (kg):

Round of Administration:

OR

Specification:

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* 20. Notes:

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* 21. Acknowledgment:

A $100 fee will be charged to your account in order to begin the quotation
process. Once initiated, this fee will be applied to the cost of the study.
Please allow 5-7 business days for your quotation to be completed.

For help, please call our Client Care Team at 800-745-8916.

Please Check This Box to Acknowledge

Stability Study Questionnaire

Question Title

* 1. Participant Information

Question Title

* 2. Organization Type

Question Title

* 3. Survey Date

Question Title

* 4. Drug Name: (As Per Sample Label)

Question Title

* 5. Active Pharmaceutical Ingredients (API) / Analytes and Concentrations (if additional APIs / Analytes & Concentrations are needed, enter information into the "Notes" section found at the end of the survey):

Question Title

* 6. Dosage Form:

Question Title

* 7. Route of Administration:

Question Title

* 8. Length of Study (Desired BUD):

Question Title

* 9. Time Points to be Tested:

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* 10. Sterile or Nonsterile

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* 11. Storage Condition:

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* 12. How many Lots are to be tested?

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* 13. Maximum Batch Size:

Question Title

* 14. Container Type: (E.g. Vial, Syringe, Etc.)

Question Title

* 15. Container Size:

Question Title

* 16. Container Fill Volume:

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* 17. Does the formula contain an antimicrobial preservative? (Select All That Apply)

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* 18. Is the product a Multidose Vial?

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* 19. USP <85> Bacterial Endotoxin Test:

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* 20. Notes:

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* 21. Acknowledgment:A $100 fee will be charged to your account in order to begin the quotationprocess. Once initiated, this fee will be applied to the cost of the study.Please allow 5-7 business days for your quotation to be completed.For help, please call our Client Care Team at 800-745-8916.