Ergocalciferol Oral Solution

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition

Issued and maintained by the United States Pharmacopeial Convention (USP)

DOWNLOAD PDF HERE

1 DEFINITION

Ergocalciferol Oral Solution is a solution of Ergocalciferol in an edible vegetable oil, in Polysorbate 80, or in Propylene Glycol. It contains NLT 100.0% and NMT 120.0% of the labeled amount of vitamin D as ergocalciferol (C₂₈H₄₄O).

2 ASSAY

Change to read:

PROCEDURE

Mobile phase: Chloroform containing alcohol as a preservative

Standard stock solution: 50 µg/mL of USP Ergocalciferol RS in chloroform. [NOTE-Prepare this solution fresh daily.]

Standard solution A: 5 µg/mL of USP Ergocalciferol RS from the Standard stock solution in chloroform, [NOTE-Store Standard solution A at a temperature not above 0^o]

Standard solution B: Transfer 5.0 mL of the Standard stock solution into a round-bottom flask fitted with a reflux condenser. Displace the air with nitrogen, and reflux for 1 h in a water bath under a nitrogen atmosphere to obtain a solution containing ergocalciferol and pre-ergocalciferol. Cool and transfer, with the aid of several portions of chloroform, to a 50-ml volumetric flask. Dilute with chloroform to volume, and mix.

Sample solution: Nominally 5 µg/mL of ergocalciferol from an accurately measured volume of Oral Solution in chloroform

Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 254 nm

Column: 4.6-mm x 25-cm; 5-µm packing L3

Flow rate: 1 mL/min

Injection volume: 10-20 µL

System suitability

Sample: Standard solution B

Suitability requirements

Relative standard deviation: NMT 2.0%

Analysis

Samples: Standard solution A, Standard solution B, and Sample solution

Ergocalciferol response factor

Calculate the Ergocalciferol response factor, F_D:

F_D = C_SA /r_SA

C_SA = concentration of USP Ergocalciferol RS in Standard solution A (µg/mL)

r_SA = peak area _{(USP 1-Dec-2021)} of ergocalciferol from Standard solution A

Pre-ergocalciferol response factor

Calculate the concentration, C_SB in µg/mL, of ergocalciferol in Standard solution B:

C_SB = F_D × r_SB

F_D = Ergocalciferol response factor

r_SB = peak area of ergocalciferol from Standard solution B

Calculate the concentration, C_pre in µg/mL, of pre-ergocalciferol in Standard solution B: _{(USP 1-Dec-2021)}

C_pre = C_SA − C_SB

C_SA = concentration of USP Ergocalciferol RS in Standard solution A (µg/mL)

C_SB = concentration of ergocalciferol in Standard solution B (µg/mL)

Calculate the Pre-ergocalciferol response factor, F_pre :

F_pre=C_pre/r_SBpre

C_pre = concentration of pre-ergocalciferol in Standard solution BA _{(USP 1-Dec-2021)} (µg/mL)

r_SBpre = peak area _{(USP 1-Dec-2021)} of pre-ergocalciferol from Standard solution B

Vitamin D content

Calculate the percentage of the labeled amount of vitamin D as ergocalciferol (C₂₈H₄₄O) in the portion of Oral Solution taken:

Result = {[(F_D × r_U ) + (F_pre × r_Upre )]/C } × 100

F_D = Ergocalciferol response factor

r_U = peak area of ergocalciferol from the Sample solution

F_pre = Pre-ergocalciferol response factor

r_Upre = peak area of pre-ergocalciferol from the Sample solution

C = nominal concentration of ergocalciferol in the Sample solution (µg/mL)

Acceptance criteria: 100.0%–120.0%

3 ADDITIONAL REQUIREMENTS

PACKAGING AND STORAGE: Preserve in tight, light-resistant containers.

Change to read:

LABELING: Label to indicate the concentration of ergocalciferol, in micrograms per dosage unit. Expression of the amount of ergocalciferol in terms of units may be added in parentheses after the mass units. _{(USP 1-Dec-2021)}

USP REFERENCE STANDARDS (11)

USP Ergocalciferol RS