Orforglipron hemicalcium hydrate/ 3008544-96-2

Product name

Orforglipron hemicalcium hydrate;

Orforglipron;

Orforglipron calcium salt hydrate;

Orforglipron monohydrate;

Orforglipron hydrate

CAS No.

3008544-96-2

Molecular Formula

C₄₈H₄₈F₂N₁₀O_5.1/2Ca.H₂O

Molecular Weight

921.02

Quality Standard

99% up by HPLC

Appearance

White to off-white powder

Test Items

Specifications

Results

Appearance

White to off-white powder

White powder

Solubility

Freely soluble in Dimethyl sulfoxide , soluble in ethanol, practically insoluble in water

Conforms

Identification

IR:The infrared absorption spectrum should be consistent with reference substance

Conforms

HPLC:The retention time of test sample major peak complies to reference substance

Conforms

Calcium salt Reaction for the Identification of calcium salts

Conforms

XRD: the characteristic diffraction peak 2θ at

 6.8± 0.2 °、10.2±0.2°、11.9±0.2°、

14.0±0.2°、16.1±0.2 °、19.2±0.2°

Conforms

Related substances

Impurity A ≤ 0.1%

ND

Any individual impurity ≤ 0.10%

0.046%

Total impurities ≤ 1.0%

0.086%

Purity ≥ 99%

99.91%

Enantiomer

≤ 0.10%

0.01%

Calcium content

1.8% - 2.5%

2.24%

Water

4.0% - 7.0%

5.32%

PSD

D90 ≤ 40μm

15.51μm

Heavy metals

≤ 20ppm

Conforms

Residual solvents

N,N-Dimethylformamide ≤ 0.088%

ND

Tetrahydrofuran ≤ 0.072%

0.002%

Ethyl acetate ≤ 0.5%

0.015%

Dichloromethane ≤ 0.06%

ND

Ethyl Alcoho ≤ 0.5%

0.3%

Microbial limit

Aerobic bacteria ≤ 103cfu/g

< 50 cfu/g

Mold and yeast ≤ 102cfu/g

< 50 cfu/g

Escherichia coliNot detectable

ND

Assay (by HPLC)

98.0%~102.0%

100.21%

Conclusion

The product conforms to the specification