Health Canada Santé Canada STATUS DECISION OF CONTROLLED AND NON-CONTROLLED SUBSTANCE(S) Substance: I- Monoammonium phosphate; II- Diammonium phosphate; III- Monocalcium phosphate; IV- Tricalcium phosphate; V- Monopotassium phosphate; VI- Dipotassium phosphate; VII- Tripotassium phosphate; VIII- Monosodium phosphate; IX- Disodium phosphate; X- Trisodium phosphate. 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” 2 Drug Status Report Drug: I- Monoammonium phosphate; II- Diammonium phosphate; III- Monocalcium phosphate; IV- Tricalcium phosphate; V- Monopotassium phosphate; VI- Dipotassium phosphate; VII- Tripotassium phosphate; VIII- Monosodium phosphate; IX- Disodium phosphate; X- Trisodium phosphate. Drug Name Status: I- Monoammonium phosphate; II- Diammonium phosphate; III- Monocalcium phosphate; IV- Tricalcium phosphate; V- Monopotassium phosphate; VI- Dipotassium phosphate; VII- Tripotassium phosphate; VIII- Monosodium phosphate; IX- Disodium phosphate; X- Trisodium phosphate are the common names. Chemical Name: I- Phosphoric acid, monoammonium salt II- Phosphoric acid, diammonium salt III- Phosphoric acid, calcium salt (1:1) IV- Phosphoric acid, calcium salt (2:3) V- Phosphoric acid, potassium salt (1:1) VI- Phosphoric acid, potassium salt (1:2) VII- Phosphoric acid, potassium salt (1:3) VIII- Phosphoric acid, sodium salt (1:1) IX- Phosphoric acid, sodium salt (1:2) X- Phosphoric acid, sodium salt (1:3) Other Names: I- Ammonium dihydrogen phosphate; Ammonium acid phosphate; Ammonium dihydrogenorthophosphate. II- Ammonium monohydrogen orthophosphate; Diammonium hydrogen phosphate; Ammonium phosphate, dibasic; Hydrogen diammonium phosphate. III- Calcium hydrogen phosphate; Calcium hydrogenorthophosphate; Calcium phosphate, dibasic. IV- Calcium orthophosphate; Calcium phosphate, tribasic; Tricalcium bis(orthophosphate). V- Potassium phosphate, monobasic; Potassium dihydrogenorthophosphate; Monopotassium monophosphate. VI- Potassium phosphate, dibasic; Dipotassium hydrogenorthophosphate; Dibasic potassium phosphate. VII- Phosphoric acid, tripotassium salt; Tripotassium orthophosphate; Potassium phosphate, tribasic. VIII- Sodium phosphate monobasic; Monosodium dihydrogen orthophosphate; Sodium dihydrogenorthophosphate; Phosphoric acid, monosodium salt. IX- Disodium hydrogenorthophosphate; Phosphoric acid, disodium salt; Sodium phosphate, dibasic. X- Phosphoric acid, trisodium salt; Trisodium orthophosphate; Sodium phosphate, tribasic. 3 Chemical structure: OH HO P O + - NH4 O I II III O O -O P O- -O P O- 2+ 2+ 2+ Ca - Ca - Ca O O IV V VI O + K -O P O- K+ O- K+ VII VIII IX X Molecular Formula: I- H6NO4P; II- H9N2O4P; III- CaHO4P; IV- Ca3O8P2; V- H2KO4P; VI- HK2O4P; VII- K3O4P; VIII- H2NaO4P; IX- HNa2O4P; X- Na3O4P. CAS-RN: I- 7722-76-1; II- 7783-28-0; III- 7757-93-9; IV- 7758-87-4; V- 7778-77-0; VI- 7758-11-4; VII- 7778-53-2; VIII- 7558-80-7; IX- 7558-79-4; X- 7601-54-9. Pharmacological class / Application: Fine chemicals International status: US: Monoammonium phosphate, diammonium phosphate, monocalcium phosphate, tricalcium phosphate, monopotassium phosphate, dipotassium phosphate, tripotassium phosphate, monosodium phosphate, disodium phosphate and trisodium phosphate are not listed specifically 4 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: Monoammonium phosphate, diammonium phosphate, monocalcium phosphate, tricalcium phosphate, monopotassium phosphate, dipotassium phosphate, tripotassium phosphate, monosodium phosphate, disodium phosphate and trisodium phosphate are not listed in the schedules to the CDSA. The substances are used in a variety of applications, such as, but not limited to, food additives, fertilizers, and buffering agents. These substances are salts of phosphoric acid, 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: Monoammonium phosphate, diammonium phosphate, monocalcium phosphate, tricalcium phosphate, monopotassium phosphate, dipotassium phosphate, tripotassium phosphate, monosodium phosphate, disodium phosphate and trisodium phosphate are not included under the schedules to the CDSA and are not controlled substances. Date: September 10th, 2013. .