Comment · Thu, August 25, 2022 · ND Owner
For those of you taking ND’s beta-ecdysterone:
Original post in this thread
AnabolicGreyhound · 23 points
- Have you noticed any tangible improvements to health markers? I.e., strength adaptions, rate of hypertrophy, recovery, or changes to bloodwork.
- Do you combine doses with other supplements or specific foods?
- Pre or post workout?
- Anyone experienced sides or cognitive effects?
Personally, I have been supplementing post workout with Schisandra and meal high in protein.
It’s too early to ascertain any impact it is or is not having as have only been supplementing a week, although I am aware numerous members of the community have been using ecdysterone for sometime now and would be interested to hear reports.
What they were answering
alainneedle1 · 1 points
That is an interesting read about Pharmaceutical grade..
u/MisterYouAreSoDumb · ND Owner
It's a meaningless buzzword. Also, there are tons of quality control issues in the pharmaceutical industry, too.
Even brand name drugs have tons of issues. Just browse the FDA enforcement letter section for drugs.
This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).
Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
That's Pfizer... Failed sterility testing.
During our inspection, we reviewed reports from multiple investigations that you conducted into complaints regarding the presence of visible particulates in several of your sterile injectable products. The presence of visible particulates in sterile injectable products is an indication of a significant loss of control in your manufacturing process and represents a severe risk of harm to patients. We documented that your investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions.
Visible particulates in Hospira's injectable drugs...
1. Failure to have adequate written procedures for the receipt, identification, testing and handling of raw materials.
Your procedures for receiving, identifying, testing, and handling raw materials were inadequate to ensure suitability of materials used in manufacturing, including preventing contamination and cross-contamination with nitrosamine impurities such as N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA). Your film had not anticipated the presence of NDMA or NDEA impurities based on your assessment of the API manufacturing process.
By December 2018, you recalled all your valsartan API batches after tests determined that the majority of batches contained NDEA contamination at levels above the limit. Your investigation dated November 21, 2018, with addendum dated January 1, 2019, concluded that NDEA contamination originated from recovered (b)(4) solvents. Your investigation into nitrosamine contamination also found that another recovered solvent, (b)(4), contained NDEA at levels of 3.38 ppm, more than 40 times your limit of 0.08 ppm. Without adequate scientific justification, you concluded that the recovered (b)(4) solvent containing high levels of NDEA would not result in significant levels of NDEA in your API.
Mylan Pharmaceuticals not properly testing raw materials for contaminants, which resulted in a recall of Valsartan. So just because a company is in the pharmaceutical industry doesn't mean they are doing quality control or lab testing right, either.