Certified Product Information Document - Chemical Entities (CPID-CE)

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(Version: 2017/10/30)

(a) Sponsor's Date of CPID:

(b) Administrative Summary: (Health Canada use only)

2.3.S Drug Substance (Name, Manufacturer)

2.3.S.1 General Information

2.3.S.1.2 Structure

(a) Structural formula, including relative and absolute stereochemistry:

(b) Molecular formula:

(c) Molecular mass:

2.3.S.1.3 General Properties

(a) Physical form (for example [e.g.], polymorphic form, solvate, hydrate):

(b) Solubilities and Dose/Solubility Volume over the physiological pH range (1.2-6.8):

(c) pK_a:

2.3.S.2 Manufacture (name, manufacturer)

2.3.S.2.1 Manufacturer(s) (name, manufacturer)

(a) Name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing:

2.3.S.2.2 Description of Manufacturing Process and process controls (name, manufacturer)

(a) Flow diagram showing reactants, solvents and reagents:

Name and address of sites manufacturing the API starting material(s) and/or intermediates:

Name and chemical structure of API starting material/intermediate:
Manufacturer:
Manufacturing site address:

S.3.2 Impurities

Potential impurities not routinely controlled in the drug substance:

2.3.S.4 Control of the Drug Substance

2.3.S.4.1 Specification (name, manufacturer)

(a) Specification for the drug substance:

2.3.S.6 Container Closure System

(a) Description of the container closure system(s) for the storage and shipment of the drug substance:

2.3.S.7 Stability

2.3.S.7.1 Stability Summary and Conclusions

(a) Proposed storage conditions and re-test period (or shelf life, as appropriate):

2.3.P Drug Product (Name, Dosage Form)

2.3.P.1 Description and Composition of the Drug Product (name, dosage form)

(a) Composition of the dosage form:

(i) Composition, that is (i.e.), list of all components of the dosage form, and their amounts on a per unit basis (including overages, if any):

(ii) Composition of all components that are mixtures (e.g., colourants, coatings, capsule shells, imprinting inks):

(b) Description of accompanying reconstitution diluent(s), if applicable:

2.3.P.3 Manufacture (name, dosage form)

2.3.P.3.1 Manufacturer(s) (name, dosage form)

(a) Name, address, and responsibility of each manufacturer, including contractors, and each proposed production site or facility involved in manufacturing and testing:

2.3.P.3.2 Batch Formula (name, dosage form)

(a) List of all components of the dosage form to be used in the manufacturing process, and their amounts on a per batch basis (including overages, if any):

2.3.P.3.3 Description of Manufacturing Process and Process Controls (name, dosage form)

(a) Flow diagram of the manufacturing process:

(b) Narrative description of the manufacturing process, including equipment type and working capacity, process parameters:

2.3.P.3.4 Controls of Critical Steps and Intermediates (name, dosage form)

(a) Summary of controls performed at the critical steps of the manufacturing process and on isolated intermediates:

2.3.P.3.5 Process Validation and/or Evaluation (name, dosage form)

(a) Summary of process validation information, including any commitments, for the critical steps in the manufacturing process (e.g., protocol number, parameters):

2.3.P.5 Control of Drug Product (name, dosage form)

2.3.P.5.1 Specification(s) (name, dosage form)

(a) Specification(s) for the drug product:

2.3.P.7 Container Closure System (name, dosage form)

(a) Description of the container closure systems, including unit count or fill size, container size or volume:

2.3.P.8 Stability (name, dosage form)

2.3.P.8.1 Stability Summary and Conclusions (name, dosage form)

(a) Proposed storage conditions and shelf life (and in-use storage conditions and in-use period, if applicable):

2.3.P.8.2 Post-approval Stability Protocol and Stability Commitment (name, dosage form)

(a) Stability protocol for commitment batches:

(b) Stability protocol for continuing (i.e., ongoing) batches:

2.3.P.8.3 Stability Data (name, dosage form)

(a) Bracketing and matrixing design for commitment and/or continuing (i.e., ongoing) batches, if applicable: