RFQ Q and A-87903.pdf

Solicitation 75D301-24-Q-78059

Q and A

Received 8/5. Answered: 8/5/2024

Page Section Question Answer

1 14 D – Table 1 Can you provide CAS numbers for all compounds?

No. That would limit the ionic pairing (salt versions) options for the compounds of interest

2 14 D – Table 1 Please confirm all 18 internal standards are intended to be in one mix

Preferably in one mix, but not more than two

3 14 D – Table 1 Please confirm the CDC is only requesting the internal standards.

That is correct, only the internal standards

4 14 D – Table 1 Please confirm there should be 5 units per kit. If not, please clarify packaging configuration.

Each one of the 5 kits should have 10 vials for a total of 50 vials

5 14 D – Table 1 How many kits total are being requested/expected?

5 kits are expected, each kit having 10 vials in them

6 14 D – Table 1 Please confirm “solvent” is water or specify solvent to use.

No solvent should be present, compounds should be freeze-dried in the vial

7 14 D – Table 1 Please confirm 5 mL serum vial is sufficient primary container

Containers should be

2 mL glass vials

8 14 D – Table 1 Please confirm the request is to freeze-dry in the vial

Correct, freeze-dry in the vial

9 14 D – Table 1 If dried down, are there specific instructions/freeze-dry recipe to follow?

There is no specific lyophilization recipe required

10 14 D – Table 1 Would any lyophilization carriers (salt or sugar) be acceptable or is the intent to have it dried down from solvent alone?

It should be dried down from solvent alone

11 14 D – Table 1 Is there specific Each kit should be kitting/packaging configuration required?

packed separately, in a manner that prevents breakage of containers

12 14 D – Table 1 Are there any special labeling requirements – graphics, label content/format?

Labels should comply with safety requirements

(indicate any hazards), product number (if any), lot number, and named

“2nd tier IS kit”

13 14 D – Table 1 Can vendor COA be used to adjust concentration, or should each RM be retested prior to formulation?

The vendor COA can be used to adjust concentration

14 14 D – Table 1 What storage conditions should be used for vials/kits?

Storage should be -20

C

15 Page 1 block

A Please confirm all kits be shipped at once to customer at the 3719 North Peachtree Rd address.

Yes, address is 3719

North Peachtree Rd, Chamblee, 30341, GA

16 14 D – Table 1 For L-Carnitine ClO4, O-malonyl, can Li salt form version be used instead?

Yes

17 14 D – Table 1 For L-Carnitine ClO4, O-malonyl, can Li salt form version be used instead?

Yes

18 14 D – Table 1 For Trisodium 2-methylcitrate racemic mixture of diastereomers, can free acid be used instead?

Yes

19 14 D – Table 1 For DL-2-Hydroxyglutaric acid, disodium salt, can D-2-

Hydroxyglutaric acid 13C5, disodium salt (non-DL mixture) be used instead?

Yes

20 14 D – Table 1 For DL-3-Hydroxyglutaric acid, disodium salt, can 3-

Hydroxyglutaric acid-2,2,3,4,4-

Yes d5 be used instead?

21 1 – block 6 A Please confirm final delivery of the kits is set for no later than

30-Sep-2024

Final delivery should be within 4 months from the date the contract is awarded