And Non-Controlled Substance(S) s2

Health Canada Santé Canada

STATUS DECISION OF CONTROLLED AND NON-CONTROLLED SUBSTANCE(S)

Substance: I- Calcium pyrophosphate; II- Tetrapotassium pyrophosphate; III- Sodium acid pyrosphosphate; IV-Tetrasodium pyrophosphate

Based on the current information available to the Office of Controlled Substances, it appears that the above substance is:

Controlled ☐ Not Controlled X under the schedules of the Controlled Drugs and Substances Act (CDSA) for the following reason(s):

 These substances are not captured under item 22 in Part 1 of Schedule VI to the CDSA.

Prepared by: ______Date: ______Vincent Marleau

Verified by: ______Date: ______Mark Kozlowski

Approved by: ______Date: ______DIRECTOR, OFFICE OF CONTROLLED SUBSTANCES

This status was requested by: “third party information removed as per agreement with applicant”

Drug Status Report Drug: I- Calcium pyrophosphate; II- Tetrapotassium pyrophosphate; III- Sodium acid pyrosphosphate; IV-Tetrasodium pyrophosphate

Drug Name Status: I- Calcium pyrophosphate; II- Tetrapotassium pyrophosphate; III- Sodium acid pyrosphosphate; IV-Tetrasodium pyrophosphate are the common names.

Chemical Name: I- Calcium diphosphate II- Potassium pyrophosphate III- Disodium dihydrogen diphosphate IV-Tetrasodium diphosphate

Other Names: I- Diphosphoric acid, calcium salt (1:2) II- Potassium diphosphate; Tetrapotassium diphosphate. III- Diphosphoric acid, disodium salt; Disodium diphosphate; SAPP. IV-Sodium pyrophosphate; Tetrasodium phosphate; TSPP.

Chemical structure: O O O O O O

P P Ca2+ K+ P P K+ Na+ P P Na+ -O O O- -O O O- - - O- O- O- O- O O O Ca2+ K+ K+ OH OH I II III

Na+ P P Na+ -O O O- O- O- Na+ Na+ IV Molecular Formula: I- Ca2O7P2; II- K4O7P2; III- Na2H2O7P2; IV- Na2O7P2

CAS-RN: I- 7790-76-3; II- 7320-34-5; III- 7758169; IV- 7722-88-5.

Pharmacological class / Application: Fine chemicals

International status: US: Calcium pyrophosphate, tetrapotassium pyrophosphate, sodium acid pyrosphosphate, and tetrasodium pyrophosphate are not listed specifically in the Schedules to the US Controlled Substances Act and are not mentioned anywhere on the DEA website. United Nations: The substances are not listed on the Yellow List - List of Narcotic Drugs under International Control, the Green List - List of Psychotropic Substances under International Control, nor the Red List - List of Precursors and Chemicals Frequently Used in the Illicit Manufacture of Narcotic Drugs and Psychotropic Substances under International Control.

Canadian Status: Calcium pyrophosphate, tetrapotassium pyrophosphate, sodium acid pyrosphosphate, and tetrasodium pyrophosphate are not listed in the schedules to the CDSA. The substances are used in a variety of applications, such as, but not limited to, abrasive agents1, food additives2, and dental products3. These substances are derivatives of phosphoric acid4, and are not captured under item 22 “Hypophosphorous acid, its salts and derivatives” of Part 1 of Schedule VI to the CDSA. These substances are not structurally similar to any other substances listed in the CDSA.

Recommendation: Calcium pyrophosphate, tetrapotassium pyrophosphate, sodium acid pyrosphosphate, and tetrasodium pyrophosphate are not included under the schedules to the CDSA and are not controlled substances.

Date: September 17th, 2013.

1 Broge, R.W. et al. (1959) Calcium pyrophosphate abrasive and dentifrice containing the same. US patent US2876168A. 2 http://www.hc-sc.gc.ca/fn-an/securit/addit/list/8-other-autre-eng.php 3 Sowinski, J. et al. (2000) A twelve-week clinical comparison of two tartar control dentifrices. J Clin Dent; 11(3):76-79. 4 Heymer, G. et al. (1974) Process for the manufacture of pyrophosphoric acid by crystallization. US patent US3853486.