CDX-403

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

not specified

Principles of method if other than guideline:

Various amounts of CDX-403 are mixed with 5 mL of water. This was rotated at 30°C overnight to dissolve. This solution was centrifuges at 4000 rpm for 30 minutes and visually inspected for insoluble lyophilized enzyme powder. The highest concentration with no visual insoluable matter is reported as the solubility of CDX-403.

GLP compliance:

not specified

Type of method:

flask method

Test material

Test material information

Constituent 1

Reference substance name:

Halohydrin dehalogenase

Cas Number:

132421-41-1

IUPAC Name:

Halohydrin dehalogenase

Test material form:

solid

Details on test material:

Lot number PF 791

Specific details on test material used for the study:

(lot# PF 791)

Results and discussion

Water solubility

Key result

Water solubility:

655 other: mg/mL

Conc. based on:

test mat.

Incubation duration:

24 h

Temp.:

30 °C

Remarks on result:

other: there is no data availble on the pH

Details on results:

The highest concentration of CDX-403 in water is achieved at 655 mg/mL. At this concentration, the solution is in a gel-like state. Adding additional lyophilized powder into this solution will making mixing impossible. As a result, the CDX-403 solubility is reported as 655 mg/mL in water.

Any other information on results incl. tables

 

The final concentration of CDX-403 is calculated based on the amount of lyophilized powder added and the final volume of the solution (Table 1). The UV_280nm absorbance of each solution is measured to confirm that the OD is within linear range (Figure 1, attached in illustrations).

Table 1. Final volume and amounds (mg) of CDX-403 in water (mL)

 

 

Weight of CDX-403 (mg)	Water (mL)	Total Volume (mL)
51.9	5.00	5.05
119.1	5.00	4.58
306.2	5.00	5.25
594.4	5.00	5.50
1002	5.00	5.80
2014	5.00	6.50
4000	5.00	8.00
6000	5.00	9.16
6000	5.00	9.61

Applicant's summary and conclusion

Conclusions:

The water solubility is 655 mg/mL in water.

Executive summary:

For solubility in water, various amounts of CDX-403 were mixed with 5 mL of water. Rotate at 30°C overnight to dissolve. Centrifuge 4000 rpm for 30 minutes and visually observe insoluble lyophilized enzyme powder. The highest concentration is reported as the solubility of CDX-403.

The highest concentration of CDX-403 in water was achieved at 655 mg/mL. At this concentration, the solution is in a gel-like state. Adding additional lyophilized powder into this solution will making mixing impossible. As a result, the CDX-403 solubility is reported as 655 mg/mL in water.